{
  "code": "KMF",
  "deviceName": "Bandage, Liquid",
  "deviceClass": "I",
  "regulationNumber": "880.5090",
  "panel": "General Hospital",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 222,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 24,
    "last12Months": 8
  },
  "reviewDays": {
    "median": 79,
    "sampleSize": 222
  },
  "recalls": {
    "total": 4,
    "recent": [
      {
        "resNumber": "Z-1541-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Family Dollar Stores, Llc.",
        "firmAsPublished": "Family Dollar Stores, Llc.",
        "reason": "Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.",
        "initiated": "2022-06-23"
      },
      {
        "resNumber": "Z-1453-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Cardinal Health 200, LLC",
        "firmAsPublished": "Cardinal Health 200, LLC",
        "reason": "Non-sterile product was shipped to customers.  Product package is labeled as both \"STERILE\" and \"NON-STERILR\" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.",
        "initiated": "2020-01-15"
      },
      {
        "resNumber": "Z-2748-2011",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Smith & Nephew, Inc.",
        "firmAsPublished": "Smith & Nephew Inc.",
        "reason": "Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products:  REMOVE Universal Adhesive Remover Wipes, UNI-SOLVE Adhesive Remover Wipes, SKIN-PREP Protective Wipes, PERI-PREP Protective Wipes, and NO-STING SKIN-PREP Protective Wipes.  These products were manufactured by H&P Industries dba The Triad Group who has initiated a recall of products manufactured i",
        "initiated": "2011-04-04"
      },
      {
        "resNumber": "Z-0710-2007",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Coloplast Corp Skin Care Div",
        "firmAsPublished": "Coloplast Corp Skin Care Div",
        "reason": "Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).",
        "initiated": "2007-02-14"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K241916",
      "deviceName": "TearRepair Liquid Skin Protectant",
      "applicant": "Optmed, Inc.",
      "company": "Optmed, Inc.",
      "decisionDate": "2024-09-27",
      "dateReceived": "2024-07-01"
    },
    {
      "kNumber": "K182733",
      "deviceName": "Rochal Bioshield Silicone Film",
      "applicant": "Rochal Industries, LLC",
      "company": "Rochal Industries, LLC",
      "decisionDate": "2019-06-27",
      "dateReceived": "2018-09-28"
    },
    {
      "kNumber": "K171148",
      "deviceName": "Aleo BME Liquid Bandage",
      "applicant": "Aleo Bme, Inc.",
      "company": "Aleo Bme, Inc.",
      "decisionDate": "2018-01-12",
      "dateReceived": "2017-04-19"
    },
    {
      "kNumber": "K153571",
      "deviceName": "Cavilon Advanced High Endurance Skin Protectant",
      "applicant": "3M Healthcare",
      "company": "3M Healthcare",
      "decisionDate": "2016-08-23",
      "dateReceived": "2015-12-15"
    },
    {
      "kNumber": "K160684",
      "deviceName": "Atteris No-Sting Skin Protectant",
      "applicant": "Rochal Industries, LLC",
      "company": "Rochal Industries, LLC",
      "decisionDate": "2016-07-26",
      "dateReceived": "2016-03-11"
    },
    {
      "kNumber": "K131384",
      "deviceName": "KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE",
      "applicant": "Kericure, Inc.",
      "company": "Kericure, Inc.",
      "decisionDate": "2014-08-07",
      "dateReceived": "2013-05-14"
    },
    {
      "kNumber": "K133443",
      "deviceName": "MARATHON NO STING LIQUID SKIN PROTECTANT",
      "applicant": "Advanced Medical Solutions (Plymouth), Ltd.",
      "company": "Advanced Medical Solutions (Plymouth), Ltd.",
      "decisionDate": "2014-07-10",
      "dateReceived": "2013-11-12"
    },
    {
      "kNumber": "K120059",
      "deviceName": "LIQUID BANDAGE",
      "applicant": "Chesson Laboratory Associates, Inc.",
      "company": "Chesson Laboratory Associates, Inc.",
      "decisionDate": "2012-05-17",
      "dateReceived": "2012-01-09"
    },
    {
      "kNumber": "K092712",
      "deviceName": "SKIN BARRIER FILM",
      "applicant": "Lodestar Products, Inc.",
      "company": "Lodestar Products, Inc.",
      "decisionDate": "2010-02-23",
      "dateReceived": "2009-09-03"
    },
    {
      "kNumber": "K083087",
      "deviceName": "ECOCEL",
      "applicant": "Polichem S.A",
      "company": "Polichem S.A",
      "decisionDate": "2009-08-07",
      "dateReceived": "2008-10-16"
    }
  ],
  "topApplicants": [
    {
      "name": "Convatec, A Division of E.R. Squibb & Sons",
      "count": 13
    },
    {
      "name": "Kendall Healthcare Products Co. Div.Of Tyco Health",
      "count": 9
    },
    {
      "name": "Bioderm, Inc.",
      "count": 7
    },
    {
      "name": "Smith & Nephew United, Inc.",
      "count": 7
    },
    {
      "name": "Innovative Technologies , Ltd.",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "Convatec Inc.",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Kendall Healthcare Products Co. Div.Of Tyco Health",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "BioDerm, Inc.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Smith & Nephew United, Inc.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Innovative Technologies , Ltd.",
      "count": 6,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "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": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "KMF (Bandage, Liquid): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "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%3AKMF"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKMF"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKMF"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKMF"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKMF"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKMF"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKMF"
    }
  ],
  "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": "2026-08-11T13:51:45.732Z"
}