{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Neuropace, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/neuropace-inc (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/neuropace-inc",
    "json_url": "https://devicerts.com/manufacturers/neuropace-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/neuropace-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/"
      },
      {
        "registry": "FDA PMA",
        "url": "https://open.fda.gov/apis/device/pma/"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-14",
    "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/neuropace-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": "Neuropace, Inc.",
    "url": "https://devicerts.com/manufacturers/neuropace-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "NEUROPACE"
    ],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [],
    "identifiers": [
      {
        "label": "DUNS",
        "value": "123369238"
      }
    ],
    "summary": "Neuropace, Inc. is a medical device manufacturer, with 39 devices listed in FDA GUDID, FDA 510(k) and FDA PMA (FDA Class III and II) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 39,
    "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": 36
      },
      {
        "registry": "FDA 510(k)",
        "devices": 2
      },
      {
        "registry": "FDA PMA",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class III",
        "devices": 36
      },
      {
        "class": "FDA Class II",
        "devices": 3
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 39,
    "total": 39,
    "all_devices_url": "https://devicerts.com/manufacturers/neuropace-inc",
    "items": [
      {
        "name": "NeuroPace® Depth Lead Kit DL-330-10-K",
        "url": "https://devicerts.com/devices/neuropace-r-depth-lead-kit-dl-330-10-k-815e067c",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Cortical Strip Lead Kit CL-335-10-K",
        "url": "https://devicerts.com/devices/neuropace-r-cortical-strip-lead-kit-cl-335-10-k-96dec667",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Programmer Kit PGM-300-K",
        "url": "https://devicerts.com/devices/neuropace-r-programmer-kit-pgm-300-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Explant Kit EX-01-K",
        "url": "https://devicerts.com/devices/explant-kit-ex-01-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Cortical Strip Lead Kit CL-325-10-K",
        "url": "https://devicerts.com/devices/neuropace-r-cortical-strip-lead-kit-cl-325-10-k-9aafec54",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "RNS® Neurostimulator Kit RNS-300M-K",
        "url": "https://devicerts.com/devices/rns-r-neurostimulator-kit-rns-300m-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Depth Lead Kit DL-330-3.5-K",
        "url": "https://devicerts.com/devices/neuropace-r-depth-lead-kit-dl-330-3-5-k-e13d8ffb",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Depth Lead Kit DL-330-3.5-K",
        "url": "https://devicerts.com/devices/neuropace-r-depth-lead-kit-dl-330-3-5-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Craniectomy Template Kit CT-01-K",
        "url": "https://devicerts.com/devices/craniectomy-template-kit-ct-01-k-2c422a2a",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Connector Cover Kit CC-01-K",
        "url": "https://devicerts.com/devices/connector-cover-kit-cc-01-k-6c7eebbb",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Remote Monitor Kit 5101",
        "url": "https://devicerts.com/devices/neuropace-r-remote-monitor-kit-5101",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "RNS® Neurostimulator Kit RNS-320-K",
        "url": "https://devicerts.com/devices/rns-r-neurostimulator-kit-rns-320-k-c97befd4",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Cortical Strip Lead Kit CL-335-10-K",
        "url": "https://devicerts.com/devices/neuropace-r-cortical-strip-lead-kit-cl-335-10-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Cortical Strip Lead Kit CL-315-10-K",
        "url": "https://devicerts.com/devices/neuropace-r-cortical-strip-lead-kit-cl-315-10-k-58e1ced1",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Remote Monitor Phone Accessories 5104",
        "url": "https://devicerts.com/devices/remote-monitor-phone-accessories-5104",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "RNS® Tablet Kit 5001",
        "url": "https://devicerts.com/devices/rns-r-tablet-kit-5001",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Craniectomy Template Kit CT-01-K",
        "url": "https://devicerts.com/devices/craniectomy-template-kit-ct-01-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Depth Lead Kit DL-344-3.5-K",
        "url": "https://devicerts.com/devices/neuropace-r-depth-lead-kit-dl-344-3-5-k-2440060f",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Depth Lead Kit DL-344-10-K",
        "url": "https://devicerts.com/devices/neuropace-r-depth-lead-kit-dl-344-10-k-97b61563",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ferrule Kit F-01-K",
        "url": "https://devicerts.com/devices/ferrule-kit-f-01-k-6ea1b8d6",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Remote Monitor Kit DTR-300-E-K",
        "url": "https://devicerts.com/devices/neuropace-r-remote-monitor-kit-dtr-300-e-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Magnet M-01",
        "url": "https://devicerts.com/devices/magnet-m-01",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Depth Lead Kit DL-330-10-K",
        "url": "https://devicerts.com/devices/neuropace-r-depth-lead-kit-dl-330-10-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Depth Lead Kit DL-344-10-K",
        "url": "https://devicerts.com/devices/neuropace-r-depth-lead-kit-dl-344-10-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Wand W-02",
        "url": "https://devicerts.com/devices/wand-w-02",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "RNS® Neurostimulator Kit RNS-320-K",
        "url": "https://devicerts.com/devices/rns-r-neurostimulator-kit-rns-320-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Patient Data Management System (PDMS) Model 4340",
        "url": "https://devicerts.com/devices/neuropace-r-patient-data-management-system-pdms-model-4340",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Lead Accessory Kit LA-02-K",
        "url": "https://devicerts.com/devices/neuropace-r-lead-accessory-kit-la-02-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Burr Hole Cover 8110",
        "url": "https://devicerts.com/devices/burr-hole-cover-8110",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ferrule Kit F-01-K",
        "url": "https://devicerts.com/devices/ferrule-kit-f-01-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Cortical Strip Lead Kit CL-325-10-K",
        "url": "https://devicerts.com/devices/neuropace-r-cortical-strip-lead-kit-cl-325-10-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Cortical Strip Lead Kit CL-315-10-K",
        "url": "https://devicerts.com/devices/neuropace-r-cortical-strip-lead-kit-cl-315-10-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Connector Cover Kit CC-01-K",
        "url": "https://devicerts.com/devices/connector-cover-kit-cc-01-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Depth Lead Kit DL-344-3.5-K",
        "url": "https://devicerts.com/devices/neuropace-r-depth-lead-kit-dl-344-3-5-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Remote Monitor Kit DTR-300-K",
        "url": "https://devicerts.com/devices/neuropace-r-remote-monitor-kit-dtr-300-k",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeuroPace® Remote Monitor Kit 5107",
        "url": "https://devicerts.com/devices/neuropace-r-remote-monitor-kit-5107",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neuropace Burr Hole Cover Model 8110",
        "url": "https://devicerts.com/devices/neuropace-burr-hole-cover-model-8110-gxr",
        "model_reference": "K123163",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2013-01-18",
        "open_recall": false
      },
      {
        "name": "Neuropace Burr Hole Cover",
        "url": "https://devicerts.com/devices/neuropace-burr-hole-cover-gxr",
        "model_reference": "K141368",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2014-07-11",
        "open_recall": false
      },
      {
        "name": "NeuroPace RNS System",
        "url": "https://devicerts.com/devices/neuropace-rns-system-p100026",
        "model_reference": "P100026",
        "device_class": "Class III",
        "registries": [
          "PMA"
        ],
        "status": "Active",
        "decision_date": "2013-11-14",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}