{
  "code": "FTL",
  "deviceName": "Mesh, Surgical, Polymeric",
  "deviceClass": "II",
  "regulationNumber": "878.3300",
  "panel": "General, Plastic Surgery",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 336,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 18879,
    "last12Months": 2001
  },
  "reviewDays": {
    "median": 89,
    "sampleSize": 336
  },
  "recalls": {
    "total": 73,
    "recent": [
      {
        "resNumber": "Z-2513-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "W. L. Gore & Associates, Inc.",
        "firmAsPublished": "W.L. Gore & Associates, Inc.",
        "reason": "Devices were labeled with an expiration date of four years and ten days rather than the validated two years.",
        "initiated": "2024-07-03"
      },
      {
        "resNumber": "Z-2241-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Davol, Inc.",
        "firmAsPublished": "Davol, Inc.",
        "reason": "Balloon may not inflate as intended. If the balloon\ndoes not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection",
        "initiated": "2023-04-25"
      },
      {
        "resNumber": "Z-2242-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Davol, Inc.",
        "firmAsPublished": "Davol, Inc.",
        "reason": "Balloon may not inflate as intended. If the balloon\ndoes not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection",
        "initiated": "2023-04-25"
      },
      {
        "resNumber": "Z-2243-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Davol, Inc.",
        "firmAsPublished": "Davol, Inc.",
        "reason": "Balloon may not inflate as intended. If the balloon\ndoes not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection",
        "initiated": "2023-04-25"
      },
      {
        "resNumber": "Z-2244-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Davol, Inc.",
        "firmAsPublished": "Davol, Inc.",
        "reason": "Balloon may not inflate as intended. If the balloon\ndoes not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection",
        "initiated": "2023-04-25"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253956",
      "deviceName": "ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)",
      "applicant": "Sofradim Production",
      "company": "Sofradim Production",
      "decisionDate": "2026-05-21",
      "dateReceived": "2025-12-10"
    },
    {
      "kNumber": "K253125",
      "deviceName": "Parietene™ Flat Sheet Mesh",
      "applicant": "Medtronic - Sofradim Production",
      "company": "Medtronic - Sofradim Production",
      "decisionDate": "2025-10-24",
      "dateReceived": "2025-09-25"
    },
    {
      "kNumber": "K251955",
      "deviceName": "Onflex™ Mesh",
      "applicant": "Davol Inc., Subsidiary of C. R. Bard, Inc.",
      "company": "Davol, Inc.",
      "decisionDate": "2025-07-24",
      "dateReceived": "2025-06-25"
    },
    {
      "kNumber": "K251557",
      "deviceName": "Bard® Mesh; Bard® Mesh Pre-Shaped",
      "applicant": "Davol, Inc.",
      "company": "Davol, Inc.",
      "decisionDate": "2025-06-12",
      "dateReceived": "2025-05-21"
    },
    {
      "kNumber": "K250869",
      "deviceName": "Parietene™ Macroporous Mesh  (PPM5050 )",
      "applicant": "Sofradim Production",
      "company": "Sofradim Production",
      "decisionDate": "2025-04-23",
      "dateReceived": "2025-03-24"
    },
    {
      "kNumber": "K250098",
      "deviceName": "Bard Soft Mesh; Bard Soft Mesh Pre-Shaped",
      "applicant": "Davol, Inc.",
      "company": "Davol, Inc.",
      "decisionDate": "2025-04-09",
      "dateReceived": "2025-01-14"
    },
    {
      "kNumber": "K243315",
      "deviceName": "ProGrip™ Self-Gripping Polypropylene Mesh",
      "applicant": "Sofradim Production",
      "company": "Sofradim Production",
      "decisionDate": "2025-01-17",
      "dateReceived": "2024-10-22"
    },
    {
      "kNumber": "K241250",
      "deviceName": "3DMax Light Mesh",
      "applicant": "Davol Inc., Subsidiary of C. R. Bard, Inc.",
      "company": "Davol, Inc.",
      "decisionDate": "2024-06-14",
      "dateReceived": "2024-05-03"
    },
    {
      "kNumber": "K232373",
      "deviceName": "Progrip™ Self-Gripping Polypropylene Mesh",
      "applicant": "Sofradim Production",
      "company": "Sofradim Production",
      "decisionDate": "2024-01-18",
      "dateReceived": "2023-08-08"
    },
    {
      "kNumber": "K233402",
      "deviceName": "Bard 3DMax Mesh",
      "applicant": "Davol Inc., Subsidiary of C. R. Bard, Inc.",
      "company": "Davol, Inc.",
      "decisionDate": "2023-11-01",
      "dateReceived": "2023-10-04"
    }
  ],
  "topApplicants": [
    {
      "name": "Sofradim Production",
      "count": 36
    },
    {
      "name": "W. L. Gore & Associates, Inc.",
      "count": 36
    },
    {
      "name": "C.R. Bard, Inc.",
      "count": 25
    },
    {
      "name": "ETHICON, Inc.",
      "count": 24
    },
    {
      "name": "Atrium Medical Corp.",
      "count": 11
    }
  ],
  "topCompanies": [
    {
      "name": "W. L. Gore & Associates, Inc.",
      "count": 37,
      "spellings": 2
    },
    {
      "name": "Sofradim Production",
      "count": 36,
      "spellings": 1
    },
    {
      "name": "C.R. Bard, Inc.",
      "count": 26,
      "spellings": 2
    },
    {
      "name": "ETHICON, INC.",
      "count": 25,
      "spellings": 2
    },
    {
      "name": "Atrium Medical Corporation",
      "count": 14,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Medtronic - Sofradim Production",
      "since": "2025-10-24",
      "kNumber": "K253125"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 559,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 693,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 767,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 691,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 612,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 741,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 559,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 513,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 534,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 608,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 795,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 900,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 831,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1061,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 468,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1001,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1072,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 476,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 368,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 413,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 578,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 222,
        "expectedLow": 39.21916237057027,
        "expectedHigh": 1013.0563798588432,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 192,
        "expectedLow": 0,
        "expectedHigh": 862.241221557788,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 370,
        "expectedLow": 0,
        "expectedHigh": 944.6738656161041,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 359,
        "expectedLow": 0,
        "expectedHigh": 953.7235166917803,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 401,
        "expectedLow": 0,
        "expectedHigh": 870.223704807693,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 352,
        "expectedLow": 0,
        "expectedHigh": 822.0374051356672,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 339,
        "expectedLow": 0,
        "expectedHigh": 1296.4947973966216,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 320,
        "expectedLow": 0,
        "expectedHigh": 845.7158104078711,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 204,
        "expectedLow": 143.96323969219927,
        "expectedHigh": 611.1838746599362,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 237,
        "expectedLow": 72.52217136194876,
        "expectedHigh": 570.0195029553985,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 187,
        "expectedLow": 29.914365694785943,
        "expectedHigh": 505.5548988685077,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 229,
        "expectedLow": 0,
        "expectedHigh": 546.0868478875675,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 305,
        "expectedLow": 38.02883657037329,
        "expectedHigh": 548.6257507044323,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 326,
        "expectedLow": 34.63364135746336,
        "expectedHigh": 467.50422988345167,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 310,
        "expectedLow": 68.18124700480593,
        "expectedHigh": 537.3328048806866,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "FTL (Mesh, Surgical, Polymeric) has two findings, most consequential first. 1 first-time filer in the last 12 months, Medtronic - Sofradim Production (K253125). The code is crowded, scoring 69 of 100 — 113 companies hold a clearance here and 2 arrived in the last 12 months (FTL:crowding).",
    "severity": 41,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Medtronic - Sofradim Production",
        "recordIds": [
          "K253125"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 69 of 100 — 113 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "FTL: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%3AFTL"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFTL"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFTL"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFTL"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFTL"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFTL"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFTL"
    }
  ],
  "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"
}