{
  "code": "KKX",
  "deviceName": "Drape, Surgical, Antimicrobial",
  "deviceClass": "II",
  "regulationNumber": "878.4370",
  "panel": "General, Plastic Surgery",
  "definition": "Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 450,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 69,
    "last12Months": 9
  },
  "reviewDays": {
    "median": 73,
    "sampleSize": 450
  },
  "recalls": {
    "total": 91,
    "recent": [
      {
        "resNumber": "Z-1889-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Unapproved design changes to the products outside of the 510(k) clearance.",
        "initiated": "2026-02-27"
      },
      {
        "resNumber": "Z-1409-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.",
        "initiated": "2026-01-07"
      },
      {
        "resNumber": "Z-2124-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.",
        "initiated": "2026-01-07"
      },
      {
        "resNumber": "Z-2520-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "O&M Halyard, Inc.",
        "firmAsPublished": "O&M HALYARD INC",
        "reason": "Surgical drape packs may have open seals, which may compromise the sterility of the product.",
        "initiated": "2025-07-17"
      },
      {
        "resNumber": "Z-1608-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "MEDLINE INDUSTRIES, LP - Northfield",
        "firmAsPublished": "MEDLINE INDUSTRIES, LP - Northfield",
        "reason": "There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.",
        "initiated": "2025-03-03"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K230645",
      "deviceName": "BeneHold™ Surgical Incise Drape with CHG antimicrobial II",
      "applicant": "Avery Dennison Medical , Ltd.",
      "company": "Avery Dennison Medical , Ltd.",
      "decisionDate": "2023-10-25",
      "dateReceived": "2023-03-08"
    },
    {
      "kNumber": "K222578",
      "deviceName": "3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)",
      "applicant": "3M Company",
      "company": "3M Company",
      "decisionDate": "2023-05-18",
      "dateReceived": "2022-08-25"
    },
    {
      "kNumber": "K202208",
      "deviceName": "BeneHold Surgical Incise Drape with CHG antimicrobial",
      "applicant": "Avery Dennison Belgie Bvba",
      "company": "Avery Dennison Belgie Bvba",
      "decisionDate": "2021-07-30",
      "dateReceived": "2020-08-06"
    },
    {
      "kNumber": "K200238",
      "deviceName": "ControlRad Sterile Cover",
      "applicant": "Controlrad, Inc.",
      "company": "Controlrad, Inc.",
      "decisionDate": "2020-04-26",
      "dateReceived": "2020-01-31"
    },
    {
      "kNumber": "K163556",
      "deviceName": "MediClear PreOp",
      "applicant": "Covalontechnologies, Inc.",
      "company": "Covalontechnologies, Inc.",
      "decisionDate": "2017-09-14",
      "dateReceived": "2016-12-19"
    },
    {
      "kNumber": "K133080",
      "deviceName": "Plus Surgical Drapes (EO Sterilized), PMDB-XXX",
      "applicant": "Foshan Nanhai Plus Medical Co, Ltd.",
      "company": "Foshan Nanhai Plus Medical Co, Ltd.",
      "decisionDate": "2015-06-24",
      "dateReceived": "2013-09-30"
    },
    {
      "kNumber": "K141324",
      "deviceName": "HONGYU DISPOSABLE SURGICAL DRAPES",
      "applicant": "Weihai Hongyu Nonwoven Fabric Products Co., Ltd.",
      "company": "Weihai Hongyu Nonwoven Fabric Products Co., Ltd.",
      "decisionDate": "2015-04-14",
      "dateReceived": "2014-05-20"
    },
    {
      "kNumber": "K140195",
      "deviceName": "SURGICAL DRAPE",
      "applicant": "Griffith-Lucas, LLC",
      "company": "Griffith-Lucas, LLC",
      "decisionDate": "2014-09-10",
      "dateReceived": "2014-01-27"
    },
    {
      "kNumber": "K140330",
      "deviceName": "3M STERI-DRAPE FABRIC SURGICAL DRAPES",
      "applicant": "3M Healthcare",
      "company": "3M Healthcare",
      "decisionDate": "2014-08-18",
      "dateReceived": "2014-02-10"
    },
    {
      "kNumber": "K141438",
      "deviceName": "WHITNEY MEDICAL SOLUTIONS ESHIELD",
      "applicant": "Whitney Medical Solutions",
      "company": "Whitney Medical Solutions",
      "decisionDate": "2014-08-14",
      "dateReceived": "2014-05-30"
    }
  ],
  "topApplicants": [
    {
      "name": "Surgikos, Inc.",
      "count": 30
    },
    {
      "name": "Procter & Gamble Mfg. Co.",
      "count": 14
    },
    {
      "name": "Customed, Inc.",
      "count": 11
    },
    {
      "name": "Deroyal Industries, Inc.",
      "count": 11
    },
    {
      "name": "Allegiance Healthcare Corp.",
      "count": 9
    }
  ],
  "topCompanies": [
    {
      "name": "Surgikos, Inc.",
      "count": 30,
      "spellings": 1
    },
    {
      "name": "Procter & Gamble Mfg. Co.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Customed, Inc",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "DeRoyal Industries Inc",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Allegiance Healthcare Corp.",
      "count": 9,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 2,
        "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": "2024-12-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 2,
        "expectedLow": 0.012958451541369046,
        "expectedHigh": 5.375087100292852,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 4.844393535622584,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 4.705880347496151,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 6.3622562673489895,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 4.677848545119514,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 4.952407119001477,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 5.19211933308283,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 7,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KKX (Drape, Surgical, Antimicrobial) has two findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1889-2026, Z-1409-2026, Z-2124-2026). The code is crowded, scoring 60 of 100 — 249 companies hold a clearance here and 0 arrived in the last 12 months (KKX:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "3 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1889-2026",
          "Z-1409-2026",
          "Z-2124-2026"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 60 of 100 — 249 companies hold a clearance here and 0 arrived in the last 12 months",
        "recordIds": [
          "KKX: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%3AKKX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKKX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKKX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKKX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKKX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKKX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKKX"
    }
  ],
  "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"
}