{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Burke, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/burke-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/burke-inc",
    "json_url": "https://devicerts.com/manufacturers/burke-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/burke-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/burke-inc",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Burke, Inc.",
    "url": "https://devicerts.com/manufacturers/burke-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [],
    "identifiers": [
      {
        "label": "DUNS",
        "value": "045093101"
      }
    ],
    "summary": "Burke, Inc. is a medical device manufacturer, with 47 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 47,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 40
      },
      {
        "registry": "FDA 510(k)",
        "devices": 7
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 45
      },
      {
        "class": "FDA Class I",
        "devices": 2
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 47,
    "total": 47,
    "all_devices_url": "https://devicerts.com/manufacturers/burke-inc",
    "items": [
      {
        "name": "Pacesaver Plus III Premier",
        "url": "https://devicerts.com/devices/pacesaver-15067",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout M-1 350",
        "url": "https://devicerts.com/devices/scout-81855a",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesaver Plus III Atlas",
        "url": "https://devicerts.com/devices/pacesaver-15083",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PaceSaver Fusion 250",
        "url": "https://devicerts.com/devices/pacesaver-17478",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout Boss 4.5 TPB",
        "url": "https://devicerts.com/devices/scout-82389",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PaceSaver Espree Atlas 5",
        "url": "https://devicerts.com/devices/pacesaver-15086",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Burke Tri-Flex II",
        "url": "https://devicerts.com/devices/burke-63398b",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesaver Plus III Junior",
        "url": "https://devicerts.com/devices/pacesaver-15070",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout RF 4-P",
        "url": "https://devicerts.com/devices/scout-82554",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout M-1 TPB",
        "url": "https://devicerts.com/devices/scout-82338",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout RF-P4 TPB-N",
        "url": "https://devicerts.com/devices/scout-82647",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesave Fusion 500",
        "url": "https://devicerts.com/devices/pacesave-15090",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout Boss 6 TPB",
        "url": "https://devicerts.com/devices/scout-82676",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout TPB",
        "url": "https://devicerts.com/devices/scout-83182",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout Boss 4.5 N/S",
        "url": "https://devicerts.com/devices/scout-82348",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesaver Espree Titan",
        "url": "https://devicerts.com/devices/pacesaver-15057",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesaver Espree' Premier",
        "url": "https://devicerts.com/devices/pacesaver-15068",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout RF-P4",
        "url": "https://devicerts.com/devices/scout-82491",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout RF-P4 W/S",
        "url": "https://devicerts.com/devices/scout-83173",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Burke Bari-Float Mattress 54\"",
        "url": "https://devicerts.com/devices/burke-63410",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout RF4",
        "url": "https://devicerts.com/devices/scout-81122",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesaver Fusion 450",
        "url": "https://devicerts.com/devices/pacesaver-15085",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Burke Bari-Float Mattress 48\"",
        "url": "https://devicerts.com/devices/burke-63187",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout Boss 6",
        "url": "https://devicerts.com/devices/scout-82628",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout Boss 6NS TPB",
        "url": "https://devicerts.com/devices/scout-82306",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout 4 P",
        "url": "https://devicerts.com/devices/scout-83181",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesaver Espree Atlas",
        "url": "https://devicerts.com/devices/pacesaver-15035",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout RF - SP",
        "url": "https://devicerts.com/devices/scout-81113a",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout Boss 6.75 TPB",
        "url": "https://devicerts.com/devices/scout-82677",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesaver Eclipse Atlas 5",
        "url": "https://devicerts.com/devices/pacesaver-15087",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout Boss 6.75",
        "url": "https://devicerts.com/devices/scout-82062",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesaver Eclipse Atlas",
        "url": "https://devicerts.com/devices/pacesaver-15073",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesaver Eclipse Premier",
        "url": "https://devicerts.com/devices/pacesaver-15072",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout RF-P4 TPB-S",
        "url": "https://devicerts.com/devices/scout-83180",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Burke Inc Tri-Flex Air",
        "url": "https://devicerts.com/devices/burke-inc-63390",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout Boss 6NS",
        "url": "https://devicerts.com/devices/scout-82250",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesaver Fusion 350",
        "url": "https://devicerts.com/devices/pacesaver-17477",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pacesaver Plus III Titan",
        "url": "https://devicerts.com/devices/pacesaver-15063",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scout M-1",
        "url": "https://devicerts.com/devices/scout-81445a",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PS Scout RF TPB",
        "url": "https://devicerts.com/devices/ps-scout-82565",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fusion",
        "url": "https://devicerts.com/devices/fusion-ini",
        "model_reference": "K061912",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2006-08-01",
        "open_recall": false
      },
      {
        "name": "Pacesaver & Scout",
        "url": "https://devicerts.com/devices/pacesaver-and-scout-ini",
        "model_reference": "K834506",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1984-01-30",
        "open_recall": false
      },
      {
        "name": "Concept Model 5200 Thermal Therapy System",
        "url": "https://devicerts.com/devices/concept-model-5200-thermal-therapy-system-ilo",
        "model_reference": "K911943",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1991-07-19",
        "open_recall": false
      },
      {
        "name": "Scout Boss",
        "url": "https://devicerts.com/devices/scout-boss-iti",
        "model_reference": "K023961",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2002-12-24",
        "open_recall": false
      },
      {
        "name": "Pace Saver, Little Junior (Modification)(Motorized Three-Wheeled Vehicle)",
        "url": "https://devicerts.com/devices/pace-saver-little-junior-modification-motorized-three-wheele-ini",
        "model_reference": "K965123",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1997-07-17",
        "open_recall": false
      },
      {
        "name": "Scout",
        "url": "https://devicerts.com/devices/scout-iti",
        "model_reference": "K982158",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1998-08-31",
        "open_recall": false
      },
      {
        "name": "Cold/Hot Fluid Radiation Pad Neutech",
        "url": "https://devicerts.com/devices/cold-hot-fluid-radiation-pad-neutech-ilo",
        "model_reference": "K893706",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1989-06-22",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}