{
  "code": "FRG",
  "deviceName": "Wrap, Sterilization",
  "deviceClass": "II",
  "regulationNumber": "880.6850",
  "panel": "General Hospital",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 323,
    "last12Months": 6
  },
  "adverseEvents": {
    "total": 61,
    "last12Months": 24
  },
  "reviewDays": {
    "median": 90,
    "sampleSize": 323
  },
  "recalls": {
    "total": 50,
    "recent": [
      {
        "resNumber": "Z-1037-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Turbett Surgical, Inc.",
        "firmAsPublished": "Turbett Surgical, Inc.",
        "reason": "Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.",
        "initiated": "2022-12-05"
      },
      {
        "resNumber": "Z-1038-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Turbett Surgical, Inc.",
        "firmAsPublished": "Turbett Surgical, Inc.",
        "reason": "Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.",
        "initiated": "2022-12-05"
      },
      {
        "resNumber": "Z-1501-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Turbett Surgical, Inc.",
        "firmAsPublished": "Turbett Surgical, Inc.",
        "reason": "Devices were subject to unapproved rework processes.",
        "initiated": "2022-04-14"
      },
      {
        "resNumber": "Z-1111-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Turbett Surgical, Inc.",
        "firmAsPublished": "TURBETT SURGICAL, LLC",
        "reason": "Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.",
        "initiated": "2022-04-01"
      },
      {
        "resNumber": "Z-0786-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Steris Corporation",
        "firmAsPublished": "Steris Corporation",
        "reason": "Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch",
        "initiated": "2020-12-02"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261897",
      "deviceName": "HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology",
      "applicant": "O&M Halyard, Inc.",
      "company": "O&M Halyard, Inc.",
      "decisionDate": "2026-07-02",
      "dateReceived": "2026-06-05"
    },
    {
      "kNumber": "K252823",
      "deviceName": "Dukal Crepe Paper Sterilization Wrap",
      "applicant": "Dukal, LLC",
      "company": "Dukal Corp.",
      "decisionDate": "2026-05-28",
      "dateReceived": "2025-09-04"
    },
    {
      "kNumber": "K253454",
      "deviceName": "HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL  Sterilization Wrap; HALYARD* SMART-FOLD*  Sterilization Wrap",
      "applicant": "O&M Halyard, Inc.",
      "company": "O&M Halyard, Inc.",
      "decisionDate": "2026-05-18",
      "dateReceived": "2025-10-03"
    },
    {
      "kNumber": "K251347",
      "deviceName": "Sterilization Pouch/Roll",
      "applicant": "Sterivic Medical Co., Ltd.",
      "company": "Sterivic Medical Co., Ltd.",
      "decisionDate": "2026-01-28",
      "dateReceived": "2025-04-30"
    },
    {
      "kNumber": "K251177",
      "deviceName": "Self-Seal Sterilization Pouch and Roll",
      "applicant": "Guangdong Maidi Medical Co., Ltd.",
      "company": "Guangdong Maidi Medical Co., Ltd.",
      "decisionDate": "2025-12-12",
      "dateReceived": "2025-04-16"
    },
    {
      "kNumber": "K250306",
      "deviceName": "Chex-All Sterilization Pouches and Tubes",
      "applicant": "Propper Manufacturing Co., Inc.",
      "company": "Propper Manufacturing Co., Inc.",
      "decisionDate": "2025-10-31",
      "dateReceived": "2025-02-03"
    },
    {
      "kNumber": "K243179",
      "deviceName": "Sterilization Pouch and Roll",
      "applicant": "Yichang Xinxin Paper Products Co., Ltd.",
      "company": "Yichang Xinxin Paper Products Co., Ltd.",
      "decisionDate": "2025-06-26",
      "dateReceived": "2024-09-30"
    },
    {
      "kNumber": "K250321",
      "deviceName": "GCI Sterilization Wrappers",
      "applicant": "George Courey, Inc.",
      "company": "George Courey, Inc.",
      "decisionDate": "2025-06-06",
      "dateReceived": "2025-02-04"
    },
    {
      "kNumber": "K243721",
      "deviceName": "Self Sealing Sterilization Pouches",
      "applicant": "Wellmed Dental Medical Supply Co., Ltd.",
      "company": "Wellmed Dental Medical Supply Co., Ltd.",
      "decisionDate": "2025-04-25",
      "dateReceived": "2024-12-03"
    },
    {
      "kNumber": "K250011",
      "deviceName": "Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)",
      "applicant": "Turbett Surgical",
      "company": "Turbett Surgical, Inc.",
      "decisionDate": "2025-04-04",
      "dateReceived": "2025-01-02"
    }
  ],
  "topApplicants": [
    {
      "name": "Cardinal Health200, LLC",
      "count": 11
    },
    {
      "name": "Kimberly-Clark Corp.",
      "count": 11
    },
    {
      "name": "Case Medical, Inc.",
      "count": 9
    },
    {
      "name": "Medline Industries, Inc.",
      "count": 9
    },
    {
      "name": "Custom Pack Reliability",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "Cardinal Health200, LLC",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Kimberly-Clark Corporation",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Medline Industries, LP",
      "count": 11,
      "spellings": 2
    },
    {
      "name": "Case Medical, Inc.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Steris Corporation",
      "count": 8,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Sterivic Medical Co., Ltd.",
      "since": "2026-01-28",
      "kNumber": "K251347"
    },
    {
      "name": "Guangdong Maidi Medical Co., Ltd.",
      "since": "2025-12-12",
      "kNumber": "K251177"
    },
    {
      "name": "Propper Manufacturing Co., Inc.",
      "since": "2025-10-31",
      "kNumber": "K250306"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "FRG (Wrap, Sterilization) has two findings, most consequential first. 3 first-time filers in the last 12 months, including Sterivic Medical Co., Ltd. and Guangdong Maidi Medical Co., Ltd (K251347, K251177, K250306). The code is crowded, scoring 87 of 100 — 171 companies hold a clearance here and 6 arrived in the last 12 months (FRG:crowding).",
    "severity": 43,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Sterivic Medical Co., Ltd. and Guangdong Maidi Medical Co., Ltd.",
        "recordIds": [
          "K251347",
          "K251177",
          "K250306"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 87 of 100 — 171 companies hold a clearance here and 6 arrived in the last 12 months",
        "recordIds": [
          "FRG: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%3AFRG"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFRG"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFRG"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFRG"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFRG"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFRG"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFRG"
    }
  ],
  "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": "2026-08-11T13:51:45.698Z"
}