{ "code": "FPA", "deviceName": "Set, Administration, Intravascular", "deviceClass": "II", "regulationNumber": "880.5440", "panel": "General Hospital", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 1174, "last12Months": 6 }, "adverseEvents": { "total": 103322, "last12Months": 24728 }, "reviewDays": { "median": 79, "sampleSize": 1174 }, "recalls": { "total": 1082, "recent": [ { "resNumber": "Z-2645-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Medela Inc", "firmAsPublished": "Medela Inc", "reason": "May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.", "initiated": "2026-06-05" }, { "resNumber": "Z-2654-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "BD SWITZERLAND SARL", "firmAsPublished": "BD SWITZERLAND SARL", "reason": "Due to engineering sample labeled \"Not for Human Use\" being inadvertently shipped it the U.S. market.", "initiated": "2026-06-04" }, { "resNumber": "Z-1774-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Molded Products Inc", "firmAsPublished": "Molded Products Inc", "reason": "Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.", "initiated": "2026-02-17" }, { "resNumber": "Z-1366-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Medline Industries, LP", "firmAsPublished": "Medline Industries, LP", "reason": "Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.", "initiated": "2025-12-31" }, { "resNumber": "Z-1111-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "ICU Medical, Inc.", "firmAsPublished": "ICU Medical, Inc.", "reason": "Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted \ntherapy, exposure to biological contaminants, air infused into the body", "initiated": "2025-12-19" } ] }, "recentClearances": [ { "kNumber": "K261530", "deviceName": "iiSure Infusion Set", "applicant": "Deka Research and Development", "company": "Deka Research and Development Corporation", "decisionDate": "2026-06-03", "dateReceived": "2026-05-08" }, { "kNumber": "K252543", "deviceName": "AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)", "applicant": "Amsino International, Inc.", "company": "Amsino International, Inc.", "decisionDate": "2026-05-04", "dateReceived": "2025-08-12" }, { "kNumber": "K251375", "deviceName": "PuraCath Firefly Needleless Connector IT (9005)", "applicant": "Puracath Medical, Inc.", "company": "Puracath Medical, Inc.", "decisionDate": "2026-02-12", "dateReceived": "2025-05-02" }, { "kNumber": "K251257", "deviceName": "nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]", "applicant": "Np Medical", "company": "Np Medical, Inc.", "decisionDate": "2025-12-04", "dateReceived": "2025-04-23" }, { "kNumber": "K250325", "deviceName": "BD Alaris Pump Infusion Set", "applicant": "Carefusion (Bd)", "company": "Carefusion (Bd)", "decisionDate": "2025-10-30", "dateReceived": "2025-02-05" }, { "kNumber": "K251814", "deviceName": "EZ™ IV Administration Set", "applicant": "Epic Medical Pte. , Ltd.", "company": "Epic Medical Pte. , Ltd.", "decisionDate": "2025-08-29", "dateReceived": "2025-06-13" }, { "kNumber": "K251854", "deviceName": "SteadiSet infusion set", "applicant": "Tandem Diabetes Care", "company": "Tandem Diabetes Care, Inc.", "decisionDate": "2025-08-06", "dateReceived": "2025-06-17" }, { "kNumber": "K243841", "deviceName": "Sparta Infusion Set for Insulin", "applicant": "Deka Research and Development", "company": "Deka Research and Development Corporation", "decisionDate": "2025-08-01", "dateReceived": "2024-12-13" }, { "kNumber": "K243392", "deviceName": "Infusomat® Space Volumetric Infusion Pump Administration Sets", "applicant": "B.Braun Medical, Inc.", "company": "B. Braun Medical, Inc.", "decisionDate": "2025-07-24", "dateReceived": "2024-10-31" }, { "kNumber": "K250616", "deviceName": "Clave™ Neutral-Displacement Needlefree Connectors", "applicant": "Icu Medical, Inc.", "company": "ICU Medical, Inc.", "decisionDate": "2025-06-05", "dateReceived": "2025-02-28" } ], "topApplicants": [ { "name": "Baxter Healthcare Corp", "count": 51 }, { "name": "Abbott Laboratories", "count": 30 }, { "name": "Y", "count": 28 }, { "name": "Icu Medical, Inc.", "count": 27 }, { "name": "Sterling Medivations, Inc.", "count": 24 } ], "topCompanies": [ { "name": "Baxter Healthcare Corporation", "count": 67, "spellings": 2 }, { "name": "Abbott Laboratories, Inc.", "count": 30, "spellings": 1 }, { "name": "Y", "count": 28, "spellings": 1 }, { "name": "ICU Medical, Inc.", "count": 27, "spellings": 1 }, { "name": "Sterling Medivations, Inc.", "count": 24, "spellings": 1 } ], "newEntrants": [ { "name": "Carefusion (Bd)", "since": "2025-10-30", "kNumber": "K250325" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 921, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 796, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 1236, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 864, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 1127, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 939, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 822, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 844, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 683, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 807, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 805, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 631, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 762, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 5900, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 7225, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 8337, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 6209, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 4576, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 4120, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 4075, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 3760, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 3147, "expectedLow": 0, "expectedHigh": 9031.568402712886, "isSufficient": true }, { "month": "2025-02-01", "observed": 2793, "expectedLow": 0, "expectedHigh": 7376.097819027605, "isSufficient": true }, { "month": "2025-03-01", "observed": 3089, "expectedLow": 0, "expectedHigh": 7732.546788708757, "isSufficient": true }, { "month": "2025-04-01", "observed": 4001, "expectedLow": 0, "expectedHigh": 7364.830547321796, "isSufficient": true }, { "month": "2025-05-01", "observed": 3887, "expectedLow": 451.8162245493104, "expectedHigh": 6487.45873534638, "isSufficient": true }, { "month": "2025-06-01", "observed": 2508, "expectedLow": 682.2066675745962, "expectedHigh": 6827.78014947611, "isSufficient": true }, { "month": "2025-07-01", "observed": 2365, "expectedLow": 1356.364561901466, "expectedHigh": 9262.875572748415, "isSufficient": true }, { "month": "2025-08-01", "observed": 2490, "expectedLow": 1058.0772170540697, "expectedHigh": 5574.040101928979, "isSufficient": true }, { "month": "2025-09-01", "observed": 2435, "expectedLow": 1210.8179280766733, "expectedHigh": 5204.0356758732205, "isSufficient": true }, { "month": "2025-10-01", "observed": 2535, "expectedLow": 950.8035764226956, "expectedHigh": 4938.144842055952, "isSufficient": true }, { "month": "2025-11-01", "observed": 2511, "expectedLow": 691.4655277923212, "expectedHigh": 4400.96800602647, "isSufficient": true }, { "month": "2025-12-01", "observed": 1838, "expectedLow": 814.788082259051, "expectedHigh": 4791.255177254028, "isSufficient": true }, { "month": "2026-01-01", "observed": 2070, "expectedLow": 444.0452960176887, "expectedHigh": 5347.886270183885, "isSufficient": true }, { "month": "2026-02-01", "observed": 2198, "expectedLow": 61.728452007375544, "expectedHigh": 4420.538029663452, "isSufficient": true }, { "month": "2026-03-01", "observed": 9667, "expectedLow": 81.63779064884902, "expectedHigh": 4802.5755135280015, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "FPA (Set, Administration, Intravascular) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2645-2026, Z-2654-2026, Z-1774-2026, Z-1366-2026, Z-1111-2026). Adverse events reported in 2026-03 ran high — 9667 reports against an expected 82 to 4803 (FPA:MAUDE:2026-03). 1 first-time filer in the last 12 months, Carefusion (Bd) (K250325). The code is crowded, scoring 81 of 100 — 461 companies hold a clearance here and 6 arrived in the last 12 months (FPA:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-2645-2026", "Z-2654-2026", "Z-1774-2026", "Z-1366-2026", "Z-1111-2026" ], "severity": 75 }, { "kind": "spike", "detail": "adverse events reported in 2026-03 ran high — 9667 reports against an expected 82 to 4803", "recordIds": [ "FPA:MAUDE:2026-03" ], "severity": 72 }, { "kind": "new_entrant", "detail": "1 first-time filer in the last 12 months, Carefusion (Bd)", "recordIds": [ "K250325" ], "severity": 41 }, { "kind": "crowding", "detail": "the code is crowded, scoring 81 of 100 — 461 companies hold a clearance here and 6 arrived in the last 12 months", "recordIds": [ "FPA: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%3AFPA" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFPA" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFPA" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFPA" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFPA" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFPA" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFPA" } ], "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": "2026-08-11T13:51:45.697Z" }