{
  "code": "FMF",
  "deviceName": "Syringe, Piston",
  "deviceClass": "II",
  "regulationNumber": "880.5860",
  "panel": "General Hospital",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 749,
    "last12Months": 13
  },
  "adverseEvents": {
    "total": 14327,
    "last12Months": 2700
  },
  "reviewDays": {
    "median": 87,
    "sampleSize": 749
  },
  "recalls": {
    "total": 305,
    "recent": [
      {
        "resNumber": "Z-2614-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Mentor Texas LP",
        "firmAsPublished": "Mentor Texas LP",
        "reason": "A single lot of expired syringes were distributed due to a distribution system control failure.",
        "initiated": "2026-04-28"
      },
      {
        "resNumber": "Z-2396-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Arrow International, Inc., Division of Teleflex Medical Inc.",
        "firmAsPublished": "ARROW INTERNATIONAL, LLC",
        "reason": "Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.",
        "initiated": "2026-04-21"
      },
      {
        "resNumber": "Z-1768-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Cardinal Health 200, LLC",
        "firmAsPublished": "Cardinal Health 200, LLC",
        "reason": "The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.",
        "initiated": "2026-02-27"
      },
      {
        "resNumber": "Z-1496-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Becton, Dickinson and Company",
        "firmAsPublished": "Becton Dickinson & Company",
        "reason": "During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.",
        "initiated": "2026-01-27"
      },
      {
        "resNumber": "Z-1961-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Integra LifeSciences Corp. (NeuroSciences)",
        "firmAsPublished": "Integra LifeSciences Corp. (NeuroSciences)",
        "reason": "Lack of sterility assurance.",
        "initiated": "2025-05-23"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260208",
      "deviceName": "Ultra-Fine™ SAFETY Insulin Syringe",
      "applicant": "embecta Medical II, LLC",
      "company": "embecta Medical II, LLC",
      "decisionDate": "2026-07-13",
      "dateReceived": "2026-01-23"
    },
    {
      "kNumber": "K253110",
      "deviceName": "Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe",
      "applicant": "Sol-Millennium Medical, Inc.",
      "company": "Sol-Millennium Medical, Inc.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2025-09-24"
    },
    {
      "kNumber": "K260514",
      "deviceName": "Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle",
      "applicant": "CMT Health PTE., Ltd.",
      "company": "CMT Health PTE., Ltd.",
      "decisionDate": "2026-06-12",
      "dateReceived": "2026-02-17"
    },
    {
      "kNumber": "K253112",
      "deviceName": "Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)",
      "applicant": "Hlb Lifescience Co., Ltd.",
      "company": "Hlb Lifescience Co., Ltd.",
      "decisionDate": "2026-05-21",
      "dateReceived": "2025-09-24"
    },
    {
      "kNumber": "K252279",
      "deviceName": "Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)",
      "applicant": "Chirana T.Injecta,A.S.",
      "company": "CHIRANA T.INJECTA, A.S.",
      "decisionDate": "2026-04-17",
      "dateReceived": "2025-07-22"
    },
    {
      "kNumber": "K253068",
      "deviceName": "Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe",
      "applicant": "CMT Health PTE., Ltd.",
      "company": "CMT Health PTE., Ltd.",
      "decisionDate": "2026-02-23",
      "dateReceived": "2025-09-22"
    },
    {
      "kNumber": "K253769",
      "deviceName": "Instylla Delivery Kit",
      "applicant": "Instylla, Inc.",
      "company": "Instylla, Inc.",
      "decisionDate": "2025-12-22",
      "dateReceived": "2025-11-25"
    },
    {
      "kNumber": "K252518",
      "deviceName": "DuoprossTM Smart Cap (Type I)",
      "applicant": "Duopross Meditech Corporate",
      "company": "Duopross Meditech Corporate",
      "decisionDate": "2025-12-17",
      "dateReceived": "2025-08-11"
    },
    {
      "kNumber": "K251089",
      "deviceName": "EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle",
      "applicant": "Exelint International, Co.",
      "company": "Exelint International, Co.",
      "decisionDate": "2025-12-12",
      "dateReceived": "2025-04-10"
    },
    {
      "kNumber": "K250192",
      "deviceName": "Verisafe Safety Retractable Insulin Syringes",
      "applicant": "Promisemed Hangzhou Meditech Co., Ltd.",
      "company": "Promisemed Hangzhou Meditech Co., Ltd.",
      "decisionDate": "2025-12-10",
      "dateReceived": "2025-01-23"
    }
  ],
  "topApplicants": [
    {
      "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic",
      "count": 23
    },
    {
      "name": "Sherwood Medical Co.",
      "count": 20
    },
    {
      "name": "Becton, Dickinson and Company",
      "count": 13
    },
    {
      "name": "Merit Medical Systems, Inc.",
      "count": 10
    },
    {
      "name": "Terumo Medical Corp.",
      "count": 10
    }
  ],
  "topCompanies": [
    {
      "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic",
      "count": 23,
      "spellings": 1
    },
    {
      "name": "Sherwood Medical Co.",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "Becton, Dickinson and Company",
      "count": 18,
      "spellings": 4
    },
    {
      "name": "Merit Medical Systems, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Terumo Medical Corporation",
      "count": 10,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "embecta Medical II, LLC",
      "since": "2026-07-13",
      "kNumber": "K260208"
    },
    {
      "name": "CHIRANA T.INJECTA, A.S.",
      "since": "2026-04-17",
      "kNumber": "K252279"
    },
    {
      "name": "Duopross Meditech Corporate",
      "since": "2025-12-17",
      "kNumber": "K252518"
    },
    {
      "name": "Exelint International, Co.",
      "since": "2025-12-12",
      "kNumber": "K251089"
    },
    {
      "name": "Cardinalhealth",
      "since": "2025-08-22",
      "kNumber": "K243660"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 690,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 302,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 513,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 386,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 387,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 442,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 318,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 473,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 385,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 493,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 432,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 459,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 552,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 496,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 354,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 483,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 360,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 371,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 349,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 352,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 421,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 314,
        "expectedLow": 200.68917910907123,
        "expectedHigh": 516.1509192577231,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 262,
        "expectedLow": 161.62413900901413,
        "expectedHigh": 438.29123326566287,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 281,
        "expectedLow": 162.37611183807508,
        "expectedHigh": 484.48630460548094,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 407,
        "expectedLow": 157.26230054556112,
        "expectedHigh": 487.72809743546173,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 387,
        "expectedLow": 219.48735897135617,
        "expectedHigh": 430.402739743092,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 366,
        "expectedLow": 262.20872965732593,
        "expectedHigh": 447.63168340158035,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 306,
        "expectedLow": 418.5283497039298,
        "expectedHigh": 710.2225598646778,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 365,
        "expectedLow": 230.9448779441764,
        "expectedHigh": 501.5935415772326,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 413,
        "expectedLow": 242.7701640315389,
        "expectedHigh": 528.1381646003806,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 364,
        "expectedLow": 249.0079836183496,
        "expectedHigh": 531.8144581253304,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 317,
        "expectedLow": 217.49923540742796,
        "expectedHigh": 472.6595853275204,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 335,
        "expectedLow": 229.8541103001943,
        "expectedHigh": 517.98442797921,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 334,
        "expectedLow": 252.62098030965433,
        "expectedHigh": 580.8803279999364,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 349,
        "expectedLow": 182.32065713897393,
        "expectedHigh": 480.3237215104683,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 354,
        "expectedLow": 205.15152564619,
        "expectedHigh": 532.4866927137524,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "FMF (Syringe, Piston) has four findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-2614-2026, Z-2396-2026, Z-1768-2026, Z-1496-2026). 5 first-time filers in the last 12 months, including embecta Medical II, LLC and CHIRANA T.INJECTA, A.S (K260208, K252279, K252518, K251089, K243660). Clearances are running 171% slower — a median 236 days over the last 12 months against 87 days all-time (elapsed calendar days, not FDA review days) (FMF:review_time:12m). The code is crowded, scoring 97 of 100 — 436 companies hold a clearance here and 13 arrived in the last 12 months (FMF:crowding).",
    "severity": 85,
    "factors": [
      {
        "kind": "recall",
        "detail": "4 recalls opened in the last 12 months and not yet terminated (Class I, Class II)",
        "recordIds": [
          "Z-2614-2026",
          "Z-2396-2026",
          "Z-1768-2026",
          "Z-1496-2026"
        ],
        "severity": 85
      },
      {
        "kind": "new_entrant",
        "detail": "5 first-time filers in the last 12 months, including embecta Medical II, LLC and CHIRANA T.INJECTA, A.S.",
        "recordIds": [
          "K260208",
          "K252279",
          "K252518",
          "K251089",
          "K243660"
        ],
        "severity": 45
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 171% slower — a median 236 days over the last 12 months against 87 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "FMF:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 97 of 100 — 436 companies hold a clearance here and 13 arrived in the last 12 months",
        "recordIds": [
          "FMF: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%3AFMF"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFMF"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFMF"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFMF"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFMF"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFMF"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFMF"
    }
  ],
  "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": "2026-08-11T13:51:45.696Z"
}