{
  "code": "KGX",
  "deviceName": "Tape And Bandage, Adhesive",
  "deviceClass": "I",
  "regulationNumber": "880.5240",
  "panel": "General Hospital",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 187,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 803,
    "last12Months": 250
  },
  "reviewDays": {
    "median": 84,
    "sampleSize": 187
  },
  "recalls": {
    "total": 48,
    "recent": [
      {
        "resNumber": "Z-1180-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GOLD STAR DISTRIBUTION INC",
        "firmAsPublished": "GOLD STAR DISTRIBUTION INC",
        "reason": "Potential exposure of rodents and rodent activity in the distribution center.",
        "initiated": "2025-12-26"
      },
      {
        "resNumber": "Z-1005-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ferndale Laboratories, Inc.",
        "firmAsPublished": "Ferndale Laboratories, Inc.",
        "reason": "Butyrate tube cracks during actuation, rendering product unusable.",
        "initiated": "2025-11-25"
      },
      {
        "resNumber": "Z-0898-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.",
        "initiated": "2025-10-27"
      },
      {
        "resNumber": "Z-0899-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.",
        "initiated": "2025-10-27"
      },
      {
        "resNumber": "Z-0900-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.",
        "initiated": "2025-10-27"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K001240",
      "deviceName": "SERAGARD INJECTION PATCH",
      "applicant": "Platinum Services, Inc.",
      "company": "Platinum Services, Inc.",
      "decisionDate": "2000-06-21",
      "dateReceived": "2000-04-18"
    },
    {
      "kNumber": "K983368",
      "deviceName": "CARE BAND ANTIBACTERIAL BANDAGES",
      "applicant": "Aso Corp.",
      "company": "ASO LLC",
      "decisionDate": "1999-02-17",
      "dateReceived": "1998-09-24"
    },
    {
      "kNumber": "K972914",
      "deviceName": "SYVEK PATCH",
      "applicant": "Marine Polymer Technologies, Inc.",
      "company": "Marine Polymer Technologies, Inc.",
      "decisionDate": "1997-12-22",
      "dateReceived": "1997-08-07"
    },
    {
      "kNumber": "K943314",
      "deviceName": "ADHESIVE BANDAGES WITH OTC DRUG",
      "applicant": "Johnson & Johnson Consumer Products, Inc.",
      "company": "Johnson & Johnson Consumer Products, Inc.",
      "decisionDate": "1996-01-17",
      "dateReceived": "1994-07-11"
    },
    {
      "kNumber": "K952606",
      "deviceName": "TARGETT PATCH",
      "applicant": "Cutting Edge Technologies, Inc.",
      "company": "Cutting Edge Technologies, Inc.",
      "decisionDate": "1995-12-21",
      "dateReceived": "1995-06-06"
    },
    {
      "kNumber": "K954007",
      "deviceName": "PARALLEL",
      "applicant": "Johnson & Johnson Consumer Products, Inc.",
      "company": "Johnson & Johnson Consumer Products, Inc.",
      "decisionDate": "1995-11-22",
      "dateReceived": "1995-08-25"
    },
    {
      "kNumber": "K944587",
      "deviceName": "DERMIVIEW HYPOALLERGENIC CLEAR TAPE",
      "applicant": "Johnson & Johnson Medical, Inc.",
      "company": "Johnson & Johnson Medical, Div. of Ethicon, Inc.",
      "decisionDate": "1995-10-30",
      "dateReceived": "1994-09-19"
    },
    {
      "kNumber": "K944588",
      "deviceName": "STERILE PLASTIC DRESSING",
      "applicant": "Smith & Nephew, Inc.",
      "company": "Smith & Nephew, Inc.",
      "decisionDate": "1994-11-07",
      "dateReceived": "1994-09-19"
    },
    {
      "kNumber": "K941788",
      "deviceName": "BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP",
      "applicant": "Johnson & Johnson Consumer Products, Inc.",
      "company": "Johnson & Johnson Consumer Products, Inc.",
      "decisionDate": "1994-10-03",
      "dateReceived": "1994-04-11"
    },
    {
      "kNumber": "K940536",
      "deviceName": "BAND-AID(TM) BRAND ADHESIVE BANDAGE",
      "applicant": "Johnson & Johnson Consumer Products, Inc.",
      "company": "Johnson & Johnson Consumer Products, Inc.",
      "decisionDate": "1994-10-03",
      "dateReceived": "1994-02-07"
    }
  ],
  "topApplicants": [
    {
      "name": "Beiersdorf, Inc.",
      "count": 15
    },
    {
      "name": "Lectec Corp.",
      "count": 8
    },
    {
      "name": "3M Company",
      "count": 6
    },
    {
      "name": "Avery Intl.",
      "count": 6
    },
    {
      "name": "Convatec, A Division of E.R. Squibb & Sons",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "Beiersdorf, Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Lectec Corp.",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "3M Company",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Avery Intl.",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Convatec Inc.",
      "count": 6,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 24,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 12,
        "expectedLow": 9.268964855157199,
        "expectedHigh": 27.76069110172113,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 18,
        "expectedLow": 7.6772966764494885,
        "expectedHigh": 20.778825036221427,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 24,
        "expectedLow": 10.30189099427441,
        "expectedHigh": 24.080245403068602,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 30,
        "expectedLow": 12.625456535811805,
        "expectedHigh": 27.191358185488493,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 33,
        "expectedLow": 12.883330456558548,
        "expectedHigh": 30.18367940811921,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 20,
        "expectedLow": 13.986912249062286,
        "expectedHigh": 37.95734413798105,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 35,
        "expectedLow": 19.16081036237442,
        "expectedHigh": 56.880059409380124,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 27,
        "expectedLow": 13.692171603845651,
        "expectedHigh": 42.271468965825804,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 35,
        "expectedLow": 14.509508914749244,
        "expectedHigh": 43.85109830970957,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 31,
        "expectedLow": 15.517695685670459,
        "expectedHigh": 45.85502761203183,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 18,
        "expectedLow": 14.505329086188004,
        "expectedHigh": 40.98427421642411,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 32,
        "expectedLow": 12.606102120141914,
        "expectedHigh": 42.47600516751058,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 34,
        "expectedLow": 16.074582006808225,
        "expectedHigh": 50.269054972813954,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 29,
        "expectedLow": 16.918847132039236,
        "expectedHigh": 39.90762171028712,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 47,
        "expectedLow": 19.260505109309687,
        "expectedHigh": 43.56702895579763,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KGX (Tape And Bandage, Adhesive) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1180-2026, Z-1005-2026, Z-0898-2026, Z-0899-2026, Z-0900-2026). Adverse events reported in 2026-03 ran high — 47 reports against an expected 19 to 44 (KGX:MAUDE:2026-03).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1180-2026",
          "Z-1005-2026",
          "Z-0898-2026",
          "Z-0899-2026",
          "Z-0900-2026"
        ],
        "severity": 75
      },
      {
        "kind": "spike",
        "detail": "adverse events reported in 2026-03 ran high — 47 reports against an expected 19 to 44",
        "recordIds": [
          "KGX:MAUDE:2026-03"
        ],
        "severity": 63
      }
    ],
    "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%3AKGX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKGX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKGX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKGX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKGX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKGX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKGX"
    }
  ],
  "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": "2026-08-11T13:51:45.731Z"
}