{
  "code": "FRO",
  "deviceName": "Dressing, Wound, Drug",
  "deviceClass": "U",
  "regulationNumber": null,
  "panel": "Unknown",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 705,
    "last12Months": 18
  },
  "adverseEvents": {
    "total": 586,
    "last12Months": 124
  },
  "reviewDays": {
    "median": 148,
    "sampleSize": 705
  },
  "recalls": {
    "total": 82,
    "recent": [
      {
        "resNumber": "Z-2677-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Convatec Inc.",
        "firmAsPublished": "ConvaTec, Inc",
        "reason": "Surgical dressing  manufactured out of specification (greater thickness).",
        "initiated": "2026-06-08"
      },
      {
        "resNumber": "Z-2275-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Oculus Technologies of Mexico, S.A. de C.V.",
        "firmAsPublished": "Oculus Technologies of Mexico, S.A. de C.V.",
        "reason": "The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.",
        "initiated": "2026-04-27"
      },
      {
        "resNumber": "Z-1363-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corp. (NeuroSciences)",
        "firmAsPublished": "Integra LifeSciences Corp. (NeuroSciences)",
        "reason": "Potential packaging failures, which could lead to a breach in the sterile barrier.",
        "initiated": "2026-01-16"
      },
      {
        "resNumber": "Z-1364-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corp. (NeuroSciences)",
        "firmAsPublished": "Integra LifeSciences Corp. (NeuroSciences)",
        "reason": "Potential packaging failures, which could lead to a breach in the sterile barrier.",
        "initiated": "2026-01-16"
      },
      {
        "resNumber": "Z-1365-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corp. (NeuroSciences)",
        "firmAsPublished": "Integra LifeSciences Corp. (NeuroSciences)",
        "reason": "Potential packaging failures, which could lead to a breach in the sterile barrier.",
        "initiated": "2026-01-16"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261023",
      "deviceName": "Microdacyn Wound Irrigation Solution",
      "applicant": "Sonoma Pharmaceuticals, Inc.",
      "company": "Sonoma Pharmaceuticals, Inc.",
      "decisionDate": "2026-06-24",
      "dateReceived": "2026-03-30"
    },
    {
      "kNumber": "K251929",
      "deviceName": "SilverCeuticals® Antimicrobial Wound Gel",
      "applicant": "Silverceuticals, Inc.",
      "company": "Silverceuticals, Inc.",
      "decisionDate": "2026-06-24",
      "dateReceived": "2025-06-23"
    },
    {
      "kNumber": "K261638",
      "deviceName": "Bonvadis®",
      "applicant": "Oneness Biotech Co., Ltd.",
      "company": "Oneness Biotech Co., Ltd.",
      "decisionDate": "2026-06-17",
      "dateReceived": "2026-05-18"
    },
    {
      "kNumber": "K254073",
      "deviceName": "StatSeal Disc",
      "applicant": "Merit Medical Systems, Inc.",
      "company": "Merit Medical Systems, Inc.",
      "decisionDate": "2026-05-13",
      "dateReceived": "2025-12-18"
    },
    {
      "kNumber": "K254191",
      "deviceName": "IWD-Gel™",
      "applicant": "InnovaCorium, Inc.",
      "company": "InnovaCorium, Inc.",
      "decisionDate": "2026-04-07",
      "dateReceived": "2025-12-23"
    },
    {
      "kNumber": "K252023",
      "deviceName": "MiraChlor Antimicrobial Wound Solution",
      "applicant": "Letus Corporation",
      "company": "Letus Corporation",
      "decisionDate": "2026-03-25",
      "dateReceived": "2025-06-30"
    },
    {
      "kNumber": "K251999",
      "deviceName": "Promogran Prisma™ Collagen Matrix with ORC and Silver",
      "applicant": "Solventum Germany GmbH",
      "company": "Solventum Germany GmbH",
      "decisionDate": "2026-03-13",
      "dateReceived": "2025-06-27"
    },
    {
      "kNumber": "K252028",
      "deviceName": "LUOFUCON® Antimicrobial Wound Gel",
      "applicant": "Huizhou Foryou Medical Co., Ltd.",
      "company": "Huizhou Foryou Medical Co., Ltd.",
      "decisionDate": "2026-03-11",
      "dateReceived": "2025-06-30"
    },
    {
      "kNumber": "K251582",
      "deviceName": "Redermax Antibacterial Wound Matrix",
      "applicant": "Beijing Kreate Medical Co., Ltd.",
      "company": "Beijing Kreate Medical Co., Ltd.",
      "decisionDate": "2026-02-02",
      "dateReceived": "2025-05-23"
    },
    {
      "kNumber": "K252568",
      "deviceName": "New Day Skin Spray",
      "applicant": "Silk Holdings, Inc.",
      "company": "Silk Holdings, Inc.",
      "decisionDate": "2026-01-23",
      "dateReceived": "2025-08-14"
    }
  ],
  "topApplicants": [
    {
      "name": "Huizhou Foryou Medical Devices Co., Ltd.",
      "count": 16
    },
    {
      "name": "Convatec, A Division of E.R. Squibb & Sons",
      "count": 13
    },
    {
      "name": "Derma Sciences, Inc.",
      "count": 12
    },
    {
      "name": "Winner Medical Co., Ltd.",
      "count": 12
    },
    {
      "name": "3M Company",
      "count": 10
    }
  ],
  "topCompanies": [
    {
      "name": "Convatec Inc.",
      "count": 23,
      "spellings": 6
    },
    {
      "name": "Advanced Medical Solutions Limited",
      "count": 19,
      "spellings": 2
    },
    {
      "name": "Huizhou Foryou Medical Devices Co., Ltd.",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Oculus Innovative Sciences, Inc.",
      "count": 14,
      "spellings": 2
    },
    {
      "name": "Derma Sciences, Inc.",
      "count": 12,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Silverceuticals, Inc.",
      "since": "2026-06-24",
      "kNumber": "K251929"
    },
    {
      "name": "Merit Medical Systems, Inc.",
      "since": "2026-05-13",
      "kNumber": "K254073"
    },
    {
      "name": "InnovaCorium, Inc.",
      "since": "2026-04-07",
      "kNumber": "K254191"
    },
    {
      "name": "Letus Corporation",
      "since": "2026-03-25",
      "kNumber": "K252023"
    },
    {
      "name": "Solventum Germany GmbH",
      "since": "2026-03-13",
      "kNumber": "K251999"
    },
    {
      "name": "Huizhou Foryou Medical Co., Ltd.",
      "since": "2026-03-11",
      "kNumber": "K252028"
    },
    {
      "name": "Beijing Kreate Medical Co., Ltd.",
      "since": "2026-02-02",
      "kNumber": "K251582"
    },
    {
      "name": "Silk Holdings, Inc.",
      "since": "2026-01-23",
      "kNumber": "K252568"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 4,
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 15,
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 34,
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 34,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 24,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
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      {
        "month": "2024-05-01",
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 30,
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        "isSufficient": false
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      {
        "month": "2024-07-01",
        "observed": 31,
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
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        "month": "2024-09-01",
        "observed": 12,
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        "isSufficient": false
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        "month": "2024-10-01",
        "observed": 27,
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        "month": "2024-11-01",
        "observed": 16,
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      {
        "month": "2024-12-01",
        "observed": 12,
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        "isSufficient": false
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      {
        "month": "2025-01-01",
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        "isSufficient": true
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        "month": "2025-02-01",
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        "expectedHigh": 27.470901985726872,
        "isSufficient": true
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        "month": "2025-03-01",
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        "expectedHigh": 32.18339854949555,
        "isSufficient": true
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        "month": "2025-04-01",
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        "expectedHigh": 37.376944987331555,
        "isSufficient": true
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        "month": "2025-05-01",
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        "isSufficient": true
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        "month": "2025-06-01",
        "observed": 14,
        "expectedLow": 1.3815063247637123,
        "expectedHigh": 33.08804216411738,
        "isSufficient": true
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        "month": "2025-07-01",
        "observed": 8,
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        "expectedHigh": 47.247535964192636,
        "isSufficient": true
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      {
        "month": "2025-08-01",
        "observed": 15,
        "expectedLow": 0,
        "expectedHigh": 31.60406372817245,
        "isSufficient": true
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      {
        "month": "2025-09-01",
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        "expectedHigh": 32.98831125967361,
        "isSufficient": true
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      {
        "month": "2025-10-01",
        "observed": 10,
        "expectedLow": 0.9938713351151776,
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        "isSufficient": true
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      {
        "month": "2025-11-01",
        "observed": 19,
        "expectedLow": 0,
        "expectedHigh": 28.824564144551545,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 8,
        "expectedLow": 0.1809695124713856,
        "expectedHigh": 33.689710381243714,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 36.87004837883298,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 24,
        "expectedLow": 0,
        "expectedHigh": 29.706164907523252,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 23,
        "expectedLow": 0,
        "expectedHigh": 36.31831413739842,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "FRO (Dressing, Wound, Drug) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2677-2026, Z-2275-2026, Z-1363-2026, Z-1364-2026, Z-1365-2026). 11 first-time filers in the last 12 months, including Silverceuticals, Inc. and Merit Medical Systems, Inc (K251929, K254073, K254191, K252023, K251999). Clearances are running 42% slower — a median 210 days over the last 12 months against 148 days all-time (elapsed calendar days, not FDA review days) (FRO:review_time:12m). The code is crowded, scoring 100 of 100 — 326 companies hold a clearance here and 18 arrived in the last 12 months (FRO:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2677-2026",
          "Z-2275-2026",
          "Z-1363-2026",
          "Z-1364-2026",
          "Z-1365-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "11 first-time filers in the last 12 months, including Silverceuticals, Inc. and Merit Medical Systems, Inc.",
        "recordIds": [
          "K251929",
          "K254073",
          "K254191",
          "K252023",
          "K251999"
        ],
        "severity": 50
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 42% slower — a median 210 days over the last 12 months against 148 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "FRO:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 100 of 100 — 326 companies hold a clearance here and 18 arrived in the last 12 months",
        "recordIds": [
          "FRO: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%3AFRO"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFRO"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFRO"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFRO"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFRO"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFRO"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFRO"
    }
  ],
  "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"
}