{ "code": "FMI", "deviceName": "Needle, Hypodermic, Single Lumen", "deviceClass": "II", "regulationNumber": "880.5570", "panel": "General Hospital", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 689, "last12Months": 9 }, "adverseEvents": { "total": 10712, "last12Months": 1156 }, "reviewDays": { "median": 91, "sampleSize": 689 }, "recalls": { "total": 308, "recent": [ { "resNumber": "Z-2118-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Waismed Ltd.", "firmAsPublished": "Waismed Ltd.", "reason": "Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.", "initiated": "2025-06-05" }, { "resNumber": "Z-2119-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Waismed Ltd.", "firmAsPublished": "Waismed Ltd.", "reason": "Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.", "initiated": "2025-06-05" }, { "resNumber": "Z-0802-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Greiner Bio-One GmbH", "firmAsPublished": "Greiner Bio-One GmbH", "reason": "The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.", "initiated": "2024-11-19" }, { "resNumber": "Z-2424-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Embecta Corp.", "firmAsPublished": "Embecta Corp.", "reason": "BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.", "initiated": "2024-06-18" }, { "resNumber": "Z-1293-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Retractable Technologies, Inc.", "firmAsPublished": "Retractable Technologies, Inc.", "reason": "The needle cannula of a retractable needle may detach from the needle holder in the patient.", "initiated": "2024-02-05" } ] }, "recentClearances": [ { "kNumber": "K260739", "deviceName": "Profoject™ Pen Needles (Model A; Model B)", "applicant": "CMT Health PTE., Ltd.", "company": "CMT Health PTE., Ltd.", "decisionDate": "2026-07-15", "dateReceived": "2026-03-06" }, { "kNumber": "K260855", "deviceName": "Profoject™ Safety Pen Needles", "applicant": "CMT Health PTE., Ltd.", "company": "CMT Health PTE., Ltd.", "decisionDate": "2026-06-10", "dateReceived": "2026-03-16" }, { "kNumber": "K254273", "deviceName": "Verisafe Safety Sterile Needles (SSN)", "applicant": "Promisemed Hangzhou Meditech Co., Ltd.", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "decisionDate": "2026-04-16", "dateReceived": "2025-12-30" }, { "kNumber": "K252908", "deviceName": "Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle", "applicant": "Sandstone Medical (Suzhou), Inc.", "company": "Sandstone Medical (Suzhou), Inc.", "decisionDate": "2026-03-25", "dateReceived": "2025-09-12" }, { "kNumber": "K253047", "deviceName": "PRESSONE™", "applicant": "Nipro Medical Corporation", "company": "Nipro Medical Corporation", "decisionDate": "2026-03-24", "dateReceived": "2025-09-22" }, { "kNumber": "K253622", "deviceName": "Safety Pen Needle", "applicant": "Ningbo Medsun Medical Co., Ltd.", "company": "Ningbo Medsun Medical Co., Ltd.", "decisionDate": "2026-03-18", "dateReceived": "2025-11-18" }, { "kNumber": "K252886", "deviceName": "Pen Needle", "applicant": "Hh Global Technology, Inc.", "company": "Hh Global Technology, Inc.", "decisionDate": "2026-01-06", "dateReceived": "2025-09-10" }, { "kNumber": "K250700", "deviceName": "Pen Injector Needle 32.5", "applicant": "Terumo Corporation", "company": "Terumo Corporation", "decisionDate": "2025-11-21", "dateReceived": "2025-03-07" }, { "kNumber": "K252631", "deviceName": "Profoject™ Disposable Needle", "applicant": "CMT Health PTE., Ltd.", "company": "CMT Health PTE., Ltd.", "decisionDate": "2025-10-16", "dateReceived": "2025-08-20" }, { "kNumber": "K250724", "deviceName": "Intraosseous Infusion Needles", "applicant": "Spectrum Vascular", "company": "Spectrum Vascular", "decisionDate": "2025-07-30", "dateReceived": "2025-03-10" } ], "topApplicants": [ { "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic", "count": 20 }, { "name": "Terumo Europe N.V.", "count": 15 }, { "name": "Sherwood Medical Co.", "count": 13 }, { "name": "Vidacare Corporation", "count": 13 }, { "name": "Promisemed Hangzhou Meditech Co., Ltd.", "count": 12 } ], "topCompanies": [ { "name": "Becton, Dickinson and Company", "count": 22, "spellings": 3 }, { "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic", "count": 20, "spellings": 1 }, { "name": "Terumo Europe N.V.", "count": 15, "spellings": 1 }, { "name": "Vidacare Corporation", "count": 14, "spellings": 2 }, { "name": "Sherwood Medical Co.", "count": 13, "spellings": 1 } ], "newEntrants": [ { "name": "Hh Global Technology, Inc.", "since": "2026-01-06", "kNumber": "K252886" }, { "name": "CMT Health PTE., Ltd.", "since": "2025-10-16", "kNumber": "K252631" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 315, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 322, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 547, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 387, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 454, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 485, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 359, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 496, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 362, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 400, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 337, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 287, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 310, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 329, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 276, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 300, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 305, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 316, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 382, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 391, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 420, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 232, "expectedLow": 257.16012170455946, "expectedHigh": 417.45202074065884, "isSufficient": true }, { "month": "2025-02-01", "observed": 228, "expectedLow": 194.30573359789514, "expectedHigh": 336.92126739158454, "isSufficient": true }, { "month": "2025-03-01", "observed": 236, "expectedLow": 202.59576911246452, "expectedHigh": 365.46103951842986, "isSufficient": true }, { "month": "2025-04-01", "observed": 218, "expectedLow": 188.4731802949541, "expectedHigh": 369.56679511893674, "isSufficient": true }, { "month": "2025-05-01", "observed": 300, "expectedLow": 150.47943507743022, "expectedHigh": 338.3411293664019, "isSufficient": true }, { "month": "2025-06-01", "observed": 198, "expectedLow": 172.2297514346451, "expectedHigh": 368.62674546055746, "isSufficient": true }, { "month": "2025-07-01", "observed": 152, "expectedLow": 218.40995110281642, "expectedHigh": 562.5098395056025, "isSufficient": true }, { "month": "2025-08-01", "observed": 166, "expectedLow": 62.470972540865525, "expectedHigh": 419.8224133902492, "isSufficient": true }, { "month": "2025-09-01", "observed": 173, "expectedLow": 23.050842819219273, "expectedHigh": 437.8028552383402, "isSufficient": true }, { "month": "2025-10-01", "observed": 153, "expectedLow": 0, "expectedHigh": 430.91028033612383, "isSufficient": true }, { "month": "2025-11-01", "observed": 137, "expectedLow": 0, "expectedHigh": 376.1370335467481, "isSufficient": true }, { "month": "2025-12-01", "observed": 174, "expectedLow": 0, "expectedHigh": 388.25608715238843, "isSufficient": true }, { "month": "2026-01-01", "observed": 143, "expectedLow": 15.216559054460543, "expectedHigh": 393.9706018843705, "isSufficient": true }, { "month": "2026-02-01", "observed": 109, "expectedLow": 0, "expectedHigh": 324.2221820996873, "isSufficient": true }, { "month": "2026-03-01", "observed": 145, "expectedLow": 0, "expectedHigh": 334.72870716340157, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "FMI (Needle, Hypodermic, Single Lumen) has two findings, most consequential first. 2 first-time filers in the last 12 months, Hh Global Technology, Inc. and CMT Health PTE., Ltd (K252886, K252631). The code is crowded, scoring 88 of 100 — 375 companies hold a clearance here and 9 arrived in the last 12 months (FMI:crowding).", "severity": 42, "factors": [ { "kind": "new_entrant", "detail": "2 first-time filers in the last 12 months, Hh Global Technology, Inc. and CMT Health PTE., Ltd.", "recordIds": [ "K252886", "K252631" ], "severity": 42 }, { "kind": "crowding", "detail": "the code is crowded, scoring 88 of 100 — 375 companies hold a clearance here and 9 arrived in the last 12 months", "recordIds": [ "FMI: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%3AFMI" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFMI" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFMI" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFMI" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFMI" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFMI" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFMI" } ], "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" }