{
  "code": "KCT",
  "deviceName": "Sterilization Wrap Containers, Trays, Cassettes & Other Accessories",
  "deviceClass": "II",
  "regulationNumber": "880.6850",
  "panel": "General Hospital",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 280,
    "last12Months": 6
  },
  "adverseEvents": {
    "total": 79,
    "last12Months": 19
  },
  "reviewDays": {
    "median": 150,
    "sampleSize": 280
  },
  "recalls": {
    "total": 38,
    "recent": [
      {
        "resNumber": "Z-2033-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Jewel Precision Sheet Metal & Machining Co, Inc.",
        "firmAsPublished": "Jewel Precision Sheet Metal & Machining Co, Inc.",
        "reason": "The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.",
        "initiated": "2025-05-23"
      },
      {
        "resNumber": "Z-2026-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Jewel Precision Sheet Metal & Machining Co, Inc.",
        "firmAsPublished": "Jewel Precision Sheet Metal & Machining Co, Inc.",
        "reason": "The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.",
        "initiated": "2025-05-22"
      },
      {
        "resNumber": "Z-2172-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Implant Direct Sybron Manufacturing, LLC",
        "firmAsPublished": "Implant Direct Sybron Manufacturing LLC",
        "reason": "The Drill stop kit contains incorrect components.",
        "initiated": "2025-05-01"
      },
      {
        "resNumber": "Z-1991-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Karl Storz Endoscopy",
        "firmAsPublished": "Karl Storz Endoscopy",
        "reason": "Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.",
        "initiated": "2023-04-06"
      },
      {
        "resNumber": "Z-1981-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Karl Storz Endoscopy",
        "firmAsPublished": "Karl Storz Endoscopy",
        "reason": "Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.",
        "initiated": "2023-04-05"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253187",
      "deviceName": "SteriBest® Sterilization Tray System",
      "applicant": "Mastel Surgical",
      "company": "MASTEL SURGICAL INC.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K260726",
      "deviceName": "Straumann® ProClean™ Cassette (041.800 ; 041.801)",
      "applicant": "Institut Straumann AG",
      "company": "Institut Straumann AG",
      "decisionDate": "2026-06-03",
      "dateReceived": "2026-03-05"
    },
    {
      "kNumber": "K252854",
      "deviceName": "SteriTite Container System with MediTray Products",
      "applicant": "Case Medical, Inc.",
      "company": "Case Medical, Inc.",
      "decisionDate": "2026-06-03",
      "dateReceived": "2025-09-08"
    },
    {
      "kNumber": "K253791",
      "deviceName": "PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid",
      "applicant": "DePuy Mitek, Inc.",
      "company": "DePuy Mitek, Inc.",
      "decisionDate": "2026-02-26",
      "dateReceived": "2025-11-28"
    },
    {
      "kNumber": "K251614",
      "deviceName": "Stainless Steel Surgical Kits",
      "applicant": "Dentsply Sirona, Inc.",
      "company": "Dentsply Sirona, Inc.",
      "decisionDate": "2026-02-06",
      "dateReceived": "2025-05-27"
    },
    {
      "kNumber": "K251756",
      "deviceName": "Sterilization Trays",
      "applicant": "Paragon Implant Mfg., LLC",
      "company": "Paragon Implant Mfg., LLC",
      "decisionDate": "2025-11-14",
      "dateReceived": "2025-06-09"
    },
    {
      "kNumber": "K251300",
      "deviceName": "Plastic Surgical Kits",
      "applicant": "Dentsply Sirona, Inc.",
      "company": "Dentsply Sirona, Inc.",
      "decisionDate": "2025-07-22",
      "dateReceived": "2025-04-28"
    },
    {
      "kNumber": "K243425",
      "deviceName": "Guided DAS Surgical Kit",
      "applicant": "Talladium España, SL",
      "company": "Talladium Espana, SL",
      "decisionDate": "2025-07-22",
      "dateReceived": "2024-11-04"
    },
    {
      "kNumber": "K243589",
      "deviceName": "PAL Sterilization Case",
      "applicant": "Microaire Surgical Instruments, LLC",
      "company": "MicroAire Surgical Instruments, LLC",
      "decisionDate": "2025-06-20",
      "dateReceived": "2024-11-20"
    },
    {
      "kNumber": "K242762",
      "deviceName": "Aesculap Aicon® Series Container System",
      "applicant": "Aesculap, Inc.",
      "company": "Aesculap, Inc.",
      "decisionDate": "2025-05-13",
      "dateReceived": "2024-09-12"
    }
  ],
  "topApplicants": [
    {
      "name": "Aesculap, Inc.",
      "count": 12
    },
    {
      "name": "STERIS Corporation",
      "count": 11
    },
    {
      "name": "Summit Medical, Inc.",
      "count": 8
    },
    {
      "name": "Jjgc Industria E Comercio DE Materiais Dentarios S.A.",
      "count": 7
    },
    {
      "name": "Intuitive Surgical, Inc.",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "Aesculap, Inc.",
      "count": 13,
      "spellings": 2
    },
    {
      "name": "Steris Corporation",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Jjgc Industria E Comercio DE Materiais Dentarios S.A.",
      "count": 10,
      "spellings": 2
    },
    {
      "name": "Summit Medical, Inc.",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Intuitive Surgical, Inc.",
      "count": 7,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "MASTEL SURGICAL INC.",
      "since": "2026-06-18",
      "kNumber": "K253187"
    },
    {
      "name": "DePuy Mitek, Inc.",
      "since": "2026-02-26",
      "kNumber": "K253791"
    },
    {
      "name": "Paragon Implant Mfg., LLC",
      "since": "2025-11-14",
      "kNumber": "K251756"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 1,
        "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": "2024-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories) has two findings, most consequential first. 3 first-time filers in the last 12 months, including MASTEL SURGICAL INC. and DePuy Mitek, Inc (K253187, K253791, K251756). The code is crowded, scoring 85 of 100 — 148 companies hold a clearance here and 6 arrived in the last 12 months (KCT:crowding).",
    "severity": 43,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including MASTEL SURGICAL INC. and DePuy Mitek, Inc.",
        "recordIds": [
          "K253187",
          "K253791",
          "K251756"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 85 of 100 — 148 companies hold a clearance here and 6 arrived in the last 12 months",
        "recordIds": [
          "KCT: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%3AKCT"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKCT"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKCT"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKCT"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKCT"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKCT"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKCT"
    }
  ],
  "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": "2026-08-11T13:51:45.729Z"
}