{
  "code": "OMP",
  "deviceName": "Negative Pressure Wound Therapy Powered Suction Pump",
  "deviceClass": "II",
  "regulationNumber": "878.4780",
  "panel": "General, Plastic Surgery",
  "definition": "For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.  The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 214,
    "last12Months": 9
  },
  "adverseEvents": {
    "total": 408,
    "last12Months": 72
  },
  "reviewDays": {
    "median": 171,
    "sampleSize": 214
  },
  "recalls": {
    "total": 47,
    "recent": [
      {
        "resNumber": "Z-1176-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "KCI USA, INC.",
        "firmAsPublished": "KCI USA, INC.",
        "reason": "Due to increase in complaints related to leak alarms",
        "initiated": "2025-01-17"
      },
      {
        "resNumber": "Z-0507-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "KCI USA, INC.",
        "firmAsPublished": "KCI USA, INC.",
        "reason": "Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.",
        "initiated": "2024-11-05"
      },
      {
        "resNumber": "Z-0516-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Smith & Nephew Medical, Ltd.",
        "firmAsPublished": "Smith & Nephew Medical, Ltd.",
        "reason": "Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.",
        "initiated": "2024-10-02"
      },
      {
        "resNumber": "Z-1596-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Smith & Nephew Medical, Ltd.",
        "firmAsPublished": "Smith & Nephew Medical, Ltd.",
        "reason": "Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump",
        "initiated": "2024-03-11"
      },
      {
        "resNumber": "Z-1597-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Smith & Nephew Medical, Ltd.",
        "firmAsPublished": "Smith & Nephew Medical, Ltd.",
        "reason": "Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump",
        "initiated": "2024-03-11"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253263",
      "deviceName": "ConvaVAC™ Negative Pressure Wound Therapy System",
      "applicant": "Convatec Limited, Gdc Building",
      "company": "Convatec Limited, Gdc Building",
      "decisionDate": "2026-06-24",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K253199",
      "deviceName": "CURASYS 2 (EMDN0003)",
      "applicant": "CG Bio Co., Ltd.",
      "company": "CG Bio Co., Ltd.",
      "decisionDate": "2026-06-23",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K260646",
      "deviceName": "RENASYS EDGE (66803126)",
      "applicant": "Smith & Nephew Medical, Ltd.",
      "company": "Smith & Nephew Medical, Ltd.",
      "decisionDate": "2026-05-27",
      "dateReceived": "2026-02-27"
    },
    {
      "kNumber": "K261291",
      "deviceName": "Nisus NPWT Canister 500-mL (CPC-500)",
      "applicant": "Cork Medical",
      "company": "CORK MEDICAL, LLC",
      "decisionDate": "2026-05-21",
      "dateReceived": "2026-04-20"
    },
    {
      "kNumber": "K254019",
      "deviceName": "Wound Geni NPWT System",
      "applicant": "Bechtel Medical, Inc.",
      "company": "Bechtel Medical, Inc.",
      "decisionDate": "2026-05-04",
      "dateReceived": "2025-12-15"
    },
    {
      "kNumber": "K253429",
      "deviceName": "Genadyne ASTRA NPWT",
      "applicant": "Genadyne Biotechnologies, Inc.",
      "company": "Genadyne Biotechnologies, Inc.",
      "decisionDate": "2026-03-12",
      "dateReceived": "2025-10-01"
    },
    {
      "kNumber": "K250586",
      "deviceName": "Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory",
      "applicant": "Deroyal Industries, Inc.",
      "company": "DeRoyal Industries Inc",
      "decisionDate": "2025-11-21",
      "dateReceived": "2025-02-27"
    },
    {
      "kNumber": "K251646",
      "deviceName": "extriCARE® 1000 Negative Pressure Wound Therapy System",
      "applicant": "Alleva Medical Devices",
      "company": "Alleva Medical Devices",
      "decisionDate": "2025-10-03",
      "dateReceived": "2025-05-29"
    },
    {
      "kNumber": "K251826",
      "deviceName": "RENASYS WOUND+  Dressing Kit with AIRLOCK Technology",
      "applicant": "Smith & Nephew Medical, Ltd.",
      "company": "Smith & Nephew Medical, Ltd.",
      "decisionDate": "2025-09-11",
      "dateReceived": "2025-06-13"
    },
    {
      "kNumber": "K243187",
      "deviceName": "Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)",
      "applicant": "Cork Medical",
      "company": "CORK MEDICAL, LLC",
      "decisionDate": "2025-06-27",
      "dateReceived": "2024-09-30"
    }
  ],
  "topApplicants": [
    {
      "name": "Kci USA, Inc.",
      "count": 26
    },
    {
      "name": "Genadyne Biotechnologies, Inc.",
      "count": 14
    },
    {
      "name": "Smith & Nephew Medical Limited",
      "count": 14
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 14
    },
    {
      "name": "Kci USA, Inc. (Kinetic Concepts, Inc.)",
      "count": 13
    }
  ],
  "topCompanies": [
    {
      "name": "KCI USA, INC.",
      "count": 26,
      "spellings": 1
    },
    {
      "name": "Smith & Nephew Medical, Ltd.",
      "count": 21,
      "spellings": 3
    },
    {
      "name": "Genadyne Biotechnologies, Inc.",
      "count": 16,
      "spellings": 2
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Kci USA, Inc. (Kinetic Concepts, Inc.)",
      "count": 13,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Convatec Limited, Gdc Building",
      "since": "2026-06-24",
      "kNumber": "K253263"
    },
    {
      "name": "Bechtel Medical, Inc.",
      "since": "2026-05-04",
      "kNumber": "K254019"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 19.613313325462066,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 16.657456943765585,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 18.665067943404196,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 14,
        "expectedLow": 0,
        "expectedHigh": 18.310732816263954,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 31,
        "expectedLow": 0,
        "expectedHigh": 19.624271454194503,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 14,
        "expectedLow": 0.42864974075692996,
        "expectedHigh": 31.12257276469712,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 13,
        "expectedLow": 0.24779739527683575,
        "expectedHigh": 47.94924449380614,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 33.75993449066671,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 14,
        "expectedLow": 0,
        "expectedHigh": 32.943307830114335,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 32.548665100112565,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 11,
        "expectedLow": 0,
        "expectedHigh": 27.843639138843884,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 10,
        "expectedLow": 0,
        "expectedHigh": 30.752111096327138,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 34.36468477815342,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 27.279273765010775,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 29.556326749682217,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "OMP (Negative Pressure Wound Therapy Powered Suction Pump) has two findings, most consequential first. 2 first-time filers in the last 12 months, Convatec Limited, Gdc Building and Bechtel Medical, Inc (K253263, K254019). The code is crowded, scoring 75 of 100 — 63 companies hold a clearance here and 9 arrived in the last 12 months (OMP:crowding).",
    "severity": 42,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Convatec Limited, Gdc Building and Bechtel Medical, Inc.",
        "recordIds": [
          "K253263",
          "K254019"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 75 of 100 — 63 companies hold a clearance here and 9 arrived in the last 12 months",
        "recordIds": [
          "OMP: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%3AOMP"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AOMP"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AOMP"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AOMP"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AOMP"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AOMP"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AOMP"
    }
  ],
  "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": "2026-08-11T13:51:45.750Z"
}