{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Circulatory Technology, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/circulatory-technology-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/circulatory-technology-inc",
    "json_url": "https://devicerts.com/manufacturers/circulatory-technology-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/circulatory-technology-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "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/circulatory-technology-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": "Circulatory Technology, Inc.",
    "url": "https://devicerts.com/manufacturers/circulatory-technology-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": "786778944"
      }
    ],
    "summary": "Circulatory Technology, Inc. is a medical device manufacturer, with 11 devices listed in FDA 510(k) and FDA GUDID (FDA Class II and I) and 7 FDA recalls as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 11,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 7,
    "fda_recalls_ongoing": 1,
    "fda_recalls_ongoing_recent": 1,
    "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 510(k)",
        "devices": 9
      },
      {
        "registry": "FDA GUDID",
        "devices": 2
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 10
      },
      {
        "class": "FDA Class I",
        "devices": 1
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 11,
    "total": 11,
    "all_devices_url": "https://devicerts.com/manufacturers/circulatory-technology-inc",
    "items": [
      {
        "name": "Better-Bladder BB14",
        "url": "https://devicerts.com/devices/better-bladder-bb14",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Bigger Better-Bladder BBB38",
        "url": "https://devicerts.com/devices/bigger-better-bladder-bbb38",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "The V Bag, Catalog Number VB1800; Vac-Box For Vacuum Assisted Venous Drainage, Catalog Number VACBOX1500",
        "url": "https://devicerts.com/devices/the-v-bag-catalog-number-vb1800-vac-box-for-vacuum-assisted-dtn",
        "model_reference": "K012942",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-11-05",
        "open_recall": false
      },
      {
        "name": "Initary Better Bladder-Pediatric",
        "url": "https://devicerts.com/devices/initary-better-bladder-pediatric-dtn",
        "model_reference": "K140321",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2014-04-17",
        "open_recall": false
      },
      {
        "name": "Better-Tubing",
        "url": "https://devicerts.com/devices/better-tubing-dwf",
        "model_reference": "K964205",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1998-04-08",
        "open_recall": false
      },
      {
        "name": "Better-Bladder (Bb)",
        "url": "https://devicerts.com/devices/better-bladder-bb-dtn",
        "model_reference": "K981284",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1998-08-12",
        "open_recall": true
      },
      {
        "name": "Pressure Relief Valve",
        "url": "https://devicerts.com/devices/pressure-relief-valve-mnj",
        "model_reference": "K941492",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1994-10-26",
        "open_recall": false
      },
      {
        "name": "The V-Bag",
        "url": "https://devicerts.com/devices/the-v-bag-dtn",
        "model_reference": "K001822",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2000-07-07",
        "open_recall": false
      },
      {
        "name": "Better-Venter",
        "url": "https://devicerts.com/devices/better-venter-dwf",
        "model_reference": "K961594",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1996-09-05",
        "open_recall": false
      },
      {
        "name": "Better-Bladder (Bb)",
        "url": "https://devicerts.com/devices/better-bladder-bb-fib",
        "model_reference": "K964337",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1997-05-23",
        "open_recall": false
      },
      {
        "name": "Pressure Infusion Cuff",
        "url": "https://devicerts.com/devices/pressure-infusion-cuff-kzd",
        "model_reference": "K942933",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1994-08-25",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1862-2021",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2021-04-27",
      "product_code": "DTN",
      "reason": "The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow."
    },
    {
      "number": "Z-0817-2018",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2017-09-22",
      "product_code": "DTN",
      "reason": "The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow."
    },
    {
      "number": "Z-1171-2018",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2017-09-22",
      "product_code": "DTN",
      "reason": "The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow."
    },
    {
      "number": "Z-0057-2017",
      "classification": "Class III",
      "status": "Terminated",
      "initiated": "2016-07-01",
      "product_code": "DTN",
      "reason": "Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm."
    },
    {
      "number": "Z-2832-2016",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2016-07-01",
      "product_code": "DTN",
      "reason": "The seal between the balloon and the housing may leak."
    },
    {
      "number": "Z-2050-2016",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2016-03-03",
      "product_code": "DTN",
      "reason": "The seal between the balloon and the housing may leak."
    },
    {
      "number": "Z-1323-2010",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2009-06-03",
      "product_code": "DTN",
      "reason": "During an FDA inspection, it was discovered that the firm had conducted a silent recall of its Bigger Better Bladder device after receiving a complaint from a hospital that the device collapsed during a procedure thereby obstructing flow."
    }
  ]
}