FDA product code · General hospital

Set, Administration, Intravascular

Name: FDA decisions, review times, recalls and adverse event reports for product code FPA
Creator: 510(k) Report

FPAClass II21 CFR 880.5440510(k) required1,178 decisions since 1976839 recalls

1,178 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 223 days (half between 138 and 279). 839 recalls name this code, 17 of them Class I. The most-cited predicate is K970855, named by 15 later devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of FPA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

FIG. 1 — FPA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FPA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do FPA devices cite most?

Devices in this code that later submissions most often claim equivalence to.

K970855Clave ConnectorIcu Medical, Inc. · 199715cite it
K944692C-Series HomepumpBlock Medical, Inc. · 199510cite it
K101677Hospira Infusion Blood SetsHospira, Inc. · 20108cite it
K972135Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical · 19978cite it
K032854Unomedical Monica Infusion SetUnomedical A/S · 20038cite it
K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 20007cite it

Which FPA devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

K202672Precision Delivery Infusion SetQuest Medical, Inc. · 202111generations
K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]…Np Medical · 202510generations
K221518NP Medical nCompass Extension Set with Stabilizing BaseNp Medical · 202210generations
K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc. · 201410generations
K200439Velano ExT Extension SetVelano Vascular · 20219generations
K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. · 20169generations

What has FDA decided in FPA lately?

K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
K261530iiSure Infusion SetDeka Research and Development · 2026
K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026
K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]…Np Medical · 2025

All 1,178 FPA decisions →

What has been recalled in FPA lately?

K942988B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number…B Braun Medical Inc · Sep 14, 2026Class II
K022209BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump…BD Switzerland Sarl · Aug 19, 2026Class I
K942988Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number…B Braun Medical Inc · Aug 4, 2026Class II
K243529Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution…Baxter Healthcare Corporation · Jun 30, 2026Class I
K05149960 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext…BD Switzerland Sarl · Jun 16, 2026Class II
K895367Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog…Medela Inc · Jun 5, 2026Class II

Related product codes

Other codes under 21 CFR 880.5440.

POQ Blood Transfusion Kit FMG Stopcock, I.V. Set PWQ Buret Administration Intravenous Kit OJA Intravenous Extension Tubing Set FPK Tubing, Fluid Delivery CAK Microfilter, Blood Transfusion NEP System/Device, Pharmacy Compounding PWH Administrations Sets With Neuraxial Connectors MJF Check Valve, Retrograde Flow (In-Line)PYR Neuraxial Administration Set - Intrathecal…LHI Set, I.V. Fluid Transfer ODI Administration Set Docking Station