{
  "code": "FXX",
  "deviceName": "Mask, Surgical",
  "deviceClass": "II",
  "regulationNumber": "878.4040",
  "panel": "General, Plastic Surgery",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 607,
    "last12Months": 9
  },
  "adverseEvents": {
    "total": 57,
    "last12Months": 14
  },
  "reviewDays": {
    "median": 128,
    "sampleSize": 607
  },
  "recalls": {
    "total": 12,
    "recent": [
      {
        "resNumber": "Z-0728-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "O&M Halyard, Inc.",
        "firmAsPublished": "O&M HALYARD, INC.",
        "reason": "Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.",
        "initiated": "2024-11-08"
      },
      {
        "resNumber": "Z-0729-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "O&M Halyard, Inc.",
        "firmAsPublished": "O&M HALYARD, INC.",
        "reason": "Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.",
        "initiated": "2024-11-08"
      },
      {
        "resNumber": "Z-1146-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "AMD Medicom Inc.",
        "firmAsPublished": "AMD Medicom Inc.",
        "reason": "Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.",
        "initiated": "2023-12-21"
      },
      {
        "resNumber": "Z-1147-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "AMD Medicom Inc.",
        "firmAsPublished": "AMD Medicom Inc.",
        "reason": "Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.",
        "initiated": "2023-12-21"
      },
      {
        "resNumber": "Z-1148-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "AMD Medicom Inc.",
        "firmAsPublished": "AMD Medicom Inc.",
        "reason": "Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.",
        "initiated": "2023-12-21"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K251967",
      "deviceName": "HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor",
      "applicant": "O&M Halyard, Inc.",
      "company": "O&M Halyard, Inc.",
      "decisionDate": "2026-03-18",
      "dateReceived": "2025-06-26"
    },
    {
      "kNumber": "K252534",
      "deviceName": "Surgical Face Mask (Ear mount)",
      "applicant": "Zhejiang Hangkang Medical Equipment Co., Ltd.",
      "company": "Zhejiang Hangkang Medical Equipment Co., Ltd.",
      "decisionDate": "2026-03-03",
      "dateReceived": "2025-08-12"
    },
    {
      "kNumber": "K253398",
      "deviceName": "Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)",
      "applicant": "Efofex, Inc.",
      "company": "Efofex, Inc.",
      "decisionDate": "2026-02-19",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K252830",
      "deviceName": "Disposable Surgical Face Mask (3P00B, C2900)",
      "applicant": "Beatles Medical Supplies (Xiantao) Co., Ltd.",
      "company": "Beatles Medical Supplies (Xiantao) Co., Ltd.",
      "decisionDate": "2026-01-12",
      "dateReceived": "2025-09-05"
    },
    {
      "kNumber": "K252650",
      "deviceName": "Disposable Medical Face Mask",
      "applicant": "Makrite Industries, Inc.",
      "company": "Makrite Industries, Inc.",
      "decisionDate": "2026-01-05",
      "dateReceived": "2025-08-22"
    },
    {
      "kNumber": "K243342",
      "deviceName": "KP Protective Face Mask",
      "applicant": "Kp Trading Co., Ltd.",
      "company": "Kp Trading Co., Ltd.",
      "decisionDate": "2025-12-22",
      "dateReceived": "2024-10-25"
    },
    {
      "kNumber": "K252941",
      "deviceName": "HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops",
      "applicant": "O&M Halyard, Inc.",
      "company": "O&M Halyard, Inc.",
      "decisionDate": "2025-12-11",
      "dateReceived": "2025-09-15"
    },
    {
      "kNumber": "K252964",
      "deviceName": "PRIMED Surgical and Procedure Masks",
      "applicant": "Primed Medical Products, Inc.",
      "company": "Primed Medical Products, Inc.",
      "decisionDate": "2025-11-04",
      "dateReceived": "2025-09-17"
    },
    {
      "kNumber": "K251902",
      "deviceName": "Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)",
      "applicant": "Vitacore Industries, Inc.",
      "company": "Vitacore Industries, Inc.",
      "decisionDate": "2025-09-17",
      "dateReceived": "2025-06-20"
    },
    {
      "kNumber": "K250082",
      "deviceName": "Procedure mask/Surgical mask/Face mask",
      "applicant": "Winner Medical Co., Ltd.",
      "company": "Winner Medical Co., Ltd.",
      "decisionDate": "2025-06-18",
      "dateReceived": "2025-01-13"
    }
  ],
  "topApplicants": [
    {
      "name": "Tecnol New Jersey Wound Care, Inc.",
      "count": 11
    },
    {
      "name": "Owens & Minor (O&M) Halyard, Inc.",
      "count": 8
    },
    {
      "name": "Anago, Inc.",
      "count": 7
    },
    {
      "name": "Protectaide, Inc.",
      "count": 7
    },
    {
      "name": "3M Company",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "Tecnol New Jersey Wound Care, Inc.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Owens & Minor (O&M) Halyard, Inc.",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Anago, Inc.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Protectaide, Inc.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "3M Company",
      "count": 6,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Zhejiang Hangkang Medical Equipment Co., Ltd.",
      "since": "2026-03-03",
      "kNumber": "K252534"
    },
    {
      "name": "Beatles Medical Supplies (Xiantao) Co., Ltd.",
      "since": "2026-01-12",
      "kNumber": "K252830"
    },
    {
      "name": "Kp Trading Co., Ltd.",
      "since": "2025-12-22",
      "kNumber": "K243342"
    },
    {
      "name": "O&M Halyard, Inc.",
      "since": "2025-12-11",
      "kNumber": "K252941"
    },
    {
      "name": "Vitacore Industries, Inc.",
      "since": "2025-09-17",
      "kNumber": "K251902"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 2,
        "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": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "FXX (Mask, Surgical) has two findings, most consequential first. 5 first-time filers in the last 12 months, including Zhejiang Hangkang Medical Equipment Co., Ltd. and Beatles Medical Supplies (Xiantao) Co., Ltd (K252534, K252830, K243342, K252941, K251902). The code is crowded, scoring 95 of 100 — 460 companies hold a clearance here and 9 arrived in the last 12 months (FXX:crowding).",
    "severity": 45,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "5 first-time filers in the last 12 months, including Zhejiang Hangkang Medical Equipment Co., Ltd. and Beatles Medical Supplies (Xiantao) Co., Ltd.",
        "recordIds": [
          "K252534",
          "K252830",
          "K243342",
          "K252941",
          "K251902"
        ],
        "severity": 45
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 95 of 100 — 460 companies hold a clearance here and 9 arrived in the last 12 months",
        "recordIds": [
          "FXX: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%3AFXX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFXX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFXX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFXX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFXX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFXX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFXX"
    }
  ],
  "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": "2026-08-11T13:51:45.699Z"
}