FDA product code · General Hospital
FPASet, Administration, Intravascular
Product code FPA covers Set, Administration, Intravascular, a Class II device regulated under 21 CFR 880.5440. FDA has cleared 1,174 devices in this code, 6 of them in the last 12 months. Median review time across the 1,174 most recent decisions is 79 days. openFDA lists 1,082 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.5440
- Review panel
- General Hospital
- Clearances
- 1,174
What is happening in FPA right now?
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).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2645-2026, Z-2654-2026, Z-1774-2026, Z-1366-2026, Z-1111-2026 |
| Adverse-event spike | Serious | FPA:MAUDE:2026-03 |
| New entrant | Worth knowing | K250325 |
| Crowding | Context | FPA:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in FPA?
FDA has cleared 1,174 devices under product code FPA since the 510(k) programme began in 1976, 6 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261530 | iiSure Infusion Set | Deka Research and Development | |
| K252543 | 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) | Amsino International, Inc. | |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical | |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (Bd) | |
| K251814 | EZ IV Administration Set | Epic Medical Pte. , Ltd. | |
| K251854 | SteadiSet infusion set | Tandem Diabetes Care | |
| K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | |
| K250616 | Clave Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. |
How long does FDA review take for FPA?
The median FDA review time for FPA is 79 days, measured across the 1,174 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in FPA?
openFDA lists 1,082 recall records against product code FPA. A recall record covers one firm's corrective action and may span many device lots.
Z-2645-2026Open, ClassifiedMedela Inc
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.
Z-2654-2026Open, ClassifiedBD SWITZERLAND SARL
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Z-1774-2026Open, ClassifiedMolded Products Inc
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.
Z-1366-2026Open, ClassifiedMedline Industries, LP
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.
Z-1111-2026Open, ClassifiedICU Medical, Inc.
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 therapy, exposure to biological contaminants, air infused into the body
Showing the 5 most recently initiated of 1,082. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for FPA?
MAUDE holds 103,322 adverse-event reports naming product code FPA, 24,728 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in FPA unusual?
One month sits above FPA's own expected range: 1 March 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 921 | Insufficient history | No expected range — too little history | |
| 796 | Insufficient history | No expected range — too little history | |
| 1,236 | Insufficient history | No expected range — too little history | |
| 864 | Insufficient history | No expected range — too little history | |
| 1,127 | Insufficient history | No expected range — too little history | |
| 939 | Insufficient history | No expected range — too little history | |
| 822 | Insufficient history | No expected range — too little history | |
| 844 | Insufficient history | No expected range — too little history | |
| 683 | Insufficient history | No expected range — too little history | |
| 807 | Insufficient history | No expected range — too little history | |
| 805 | Insufficient history | No expected range — too little history | |
| 631 | Insufficient history | No expected range — too little history | |
| 762 | Insufficient history | No expected range — too little history | |
| 5,900 | Insufficient history | No expected range — too little history | |
| 7,225 | Insufficient history | No expected range — too little history | |
| 8,337 | Insufficient history | No expected range — too little history | |
| 6,209 | Insufficient history | No expected range — too little history | |
| 4,576 | Insufficient history | No expected range — too little history | |
| 4,120 | Insufficient history | No expected range — too little history | |
| 4,075 | Insufficient history | No expected range — too little history | |
| 3,760 | Insufficient history | No expected range — too little history | |
| 3,147 | 0–9,032 | Within expected (0–9,032) | |
| 2,793 | 0–7,376 | Within expected (0–7,376) | |
| 3,089 | 0–7,733 | Within expected (0–7,733) | |
| 4,001 | 0–7,365 | Within expected (0–7,365) | |
| 3,887 | 452–6,487 | Within expected (452–6,487) | |
| 2,508 | 682–6,828 | Within expected (682–6,828) | |
| 2,365 | 1,356–9,263 | Within expected (1,356–9,263) | |
| 2,490 | 1,058–5,574 | Within expected (1,058–5,574) | |
| 2,435 | 1,211–5,204 | Within expected (1,211–5,204) | |
| 2,535 | 951–4,938 | Within expected (951–4,938) | |
| 2,511 | 691–4,401 | Within expected (691–4,401) | |
| 1,838 | 815–4,791 | Within expected (815–4,791) | |
| 2,070 | 444–5,348 | Within expected (444–5,348) | |
| 2,198 | 62–4,421 | Within expected (62–4,421) | |
| 9,667 | 82–4,803 | Above expected (82–4,803) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in FPA.
Who has entered FPA in the last year?
One company filed in FPA for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Carefusion (Bd) | K250325 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in FPA?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in FPA?
Across the 1,174 most recent decisions, these applicants filed most often in FPA.
| Applicant | Recent clearances |
|---|---|
| Baxter Healthcare Corp | 51 |
| Abbott Laboratories | 30 |
| Y | 28 |
| Icu Medical, Inc. | 27 |
| Sterling Medivations, Inc. | 24 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in FPA files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Baxter Healthcare Corporation | 67 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch FPA
Get an email the morning anything changes in FPA — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.