{
  "code": "KGN",
  "deviceName": "Wound Dressing With Animal-Derived Material(S)",
  "deviceClass": "U",
  "regulationNumber": null,
  "panel": "Unknown",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 190,
    "last12Months": 17
  },
  "adverseEvents": {
    "total": 37,
    "last12Months": 8
  },
  "reviewDays": {
    "median": 119,
    "sampleSize": 190
  },
  "recalls": {
    "total": 23,
    "recent": [
      {
        "resNumber": "Z-1816-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corp. (NeuroSciences)",
        "firmAsPublished": "Integra LifeSciences Corp. (NeuroSciences)",
        "reason": "Increased rate of out-of-specification endotoxin results.",
        "initiated": "2026-03-19"
      },
      {
        "resNumber": "Z-1817-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corp. (NeuroSciences)",
        "firmAsPublished": "Integra LifeSciences Corp. (NeuroSciences)",
        "reason": "Increased rate of out-of-specification endotoxin results.",
        "initiated": "2026-03-19"
      },
      {
        "resNumber": "Z-1818-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corp. (NeuroSciences)",
        "firmAsPublished": "Integra LifeSciences Corp. (NeuroSciences)",
        "reason": "Increased rate of out-of-specification endotoxin results.",
        "initiated": "2026-03-19"
      },
      {
        "resNumber": "Z-1819-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corp. (NeuroSciences)",
        "firmAsPublished": "Integra LifeSciences Corp. (NeuroSciences)",
        "reason": "Increased rate of out-of-specification endotoxin results.",
        "initiated": "2026-03-19"
      },
      {
        "resNumber": "Z-1820-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corp. (NeuroSciences)",
        "firmAsPublished": "Integra LifeSciences Corp. (NeuroSciences)",
        "reason": "Increased rate of out-of-specification endotoxin results.",
        "initiated": "2026-03-19"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260596",
      "deviceName": "Collagen Wound Powder",
      "applicant": "Ventris Medical",
      "company": "Ventris Medical",
      "decisionDate": "2026-07-02",
      "dateReceived": "2026-02-24"
    },
    {
      "kNumber": "K260669",
      "deviceName": "Endoform Dermal Template",
      "applicant": "Aroa Biosurgery , Ltd.",
      "company": "AROA Biosurgery, LTD.",
      "decisionDate": "2026-06-24",
      "dateReceived": "2026-03-02"
    },
    {
      "kNumber": "K253521",
      "deviceName": "ECMT-100 WMD",
      "applicant": "Ecm Therapeutics, Inc.",
      "company": "Ecm Therapeutics, Inc.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2025-11-13"
    },
    {
      "kNumber": "K253204",
      "deviceName": "Catalyze",
      "applicant": "BioTissue Holdings, Inc.",
      "company": "BioTissue Holdings, Inc.",
      "decisionDate": "2026-06-05",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K254034",
      "deviceName": "Roosin Collagen Powder",
      "applicant": "Roosin Medical Co., Ltd.",
      "company": "Roosin Medical Co., Ltd.",
      "decisionDate": "2026-06-03",
      "dateReceived": "2025-12-16"
    },
    {
      "kNumber": "K253974",
      "deviceName": "Roosin Collagen Dressing",
      "applicant": "Roosin Medical Co., Ltd.",
      "company": "Roosin Medical Co., Ltd.",
      "decisionDate": "2026-06-03",
      "dateReceived": "2025-12-11"
    },
    {
      "kNumber": "K261224",
      "deviceName": "MatriDerm",
      "applicant": "Medskin Solutions Dr. Suwelack AG",
      "company": "Medskin Solutions Dr. Suwelack AG",
      "decisionDate": "2026-05-14",
      "dateReceived": "2026-04-14"
    },
    {
      "kNumber": "K260532",
      "deviceName": "Derma-Gide",
      "applicant": "Geistlich Pharma AG",
      "company": "Geistlich Pharma AG",
      "decisionDate": "2026-03-19",
      "dateReceived": "2026-02-17"
    },
    {
      "kNumber": "K260218",
      "deviceName": "LacertaMatrix",
      "applicant": "Lacerta Life Sciences",
      "company": "Lacerta Life Sciences",
      "decisionDate": "2026-02-19",
      "dateReceived": "2026-01-23"
    },
    {
      "kNumber": "K253140",
      "deviceName": "CollOvine™ Wound Powder",
      "applicant": "Ovigenex, LLC",
      "company": "Ovigenex, LLC",
      "decisionDate": "2026-02-10",
      "dateReceived": "2025-09-25"
    }
  ],
  "topApplicants": [
    {
      "name": "Acell, Inc.",
      "count": 13
    },
    {
      "name": "Collagen Matrix, Inc.",
      "count": 8
    },
    {
      "name": "Innocoll Pharmaceuticals",
      "count": 6
    },
    {
      "name": "Geistlich Pharma AG",
      "count": 5
    },
    {
      "name": "Integra Lifesciences Corp.",
      "count": 5
    }
  ],
  "topCompanies": [
    {
      "name": "ACell, Inc",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Collagen Matrix, Inc.",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Innocoll Pharmaceuticals, Ltd.",
      "count": 8,
      "spellings": 2
    },
    {
      "name": "Integra LifeSciences Corporation",
      "count": 7,
      "spellings": 2
    },
    {
      "name": "Cook Biotech, Inc.",
      "count": 6,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Ventris Medical",
      "since": "2026-07-02",
      "kNumber": "K260596"
    },
    {
      "name": "Ecm Therapeutics, Inc.",
      "since": "2026-06-18",
      "kNumber": "K253521"
    },
    {
      "name": "BioTissue Holdings, Inc.",
      "since": "2026-06-05",
      "kNumber": "K253204"
    },
    {
      "name": "Roosin Medical Co., Ltd.",
      "since": "2026-06-03",
      "kNumber": "K253974"
    },
    {
      "name": "Lacerta Life Sciences",
      "since": "2026-02-19",
      "kNumber": "K260218"
    },
    {
      "name": "Lacerta Life Science",
      "since": "2025-12-22",
      "kNumber": "K252673"
    },
    {
      "name": "Helios Biomedical, Inc.",
      "since": "2025-08-15",
      "kNumber": "K250397"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "KGN (Wound Dressing With Animal-Derived Material(S)) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1816-2026, Z-1817-2026, Z-1818-2026, Z-1819-2026, Z-1820-2026). 7 first-time filers in the last 12 months, including Ventris Medical and Ecm Therapeutics, Inc (K260596, K253521, K253204, K253974, K260218). The code is crowded, scoring 91 of 100 — 90 companies hold a clearance here and 17 arrived in the last 12 months (KGN:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1816-2026",
          "Z-1817-2026",
          "Z-1818-2026",
          "Z-1819-2026",
          "Z-1820-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "7 first-time filers in the last 12 months, including Ventris Medical and Ecm Therapeutics, Inc.",
        "recordIds": [
          "K260596",
          "K253521",
          "K253204",
          "K253974",
          "K260218"
        ],
        "severity": 47
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 91 of 100 — 90 companies hold a clearance here and 17 arrived in the last 12 months",
        "recordIds": [
          "KGN:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AKGN"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKGN"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKGN"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKGN"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKGN"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKGN"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKGN"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.730Z"
}