FPAFDA Class 2 · 21 CFR 880.5440
Set, Administration, Intravascular
Device family · General Hospital
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
1,172
Manufacturers
124
Flagged signals
20
Adverse-event reports
181,974
Code matrix
| FDA product code | FPA |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 6 | 285.0 | 1,428 |
| Other | 2010 | 3 | 142.5 | 292 |
| Other | 2011 | 4 | 115.7 | 348 |
| Other | 2013 | 3 | 105.0 | 214 |
| Death | 2019 | 3 | 85.2 | 174 |
| Other | 2024 | 3 | 12.3 | 21 |
| Other | 2013 | 26 | 9.4 | 187 |
| Other | 2011 | 8 | 8.4 | 45 |
| Other | 2010 | 8 | 8.4 | 45 |
| Other | 2010 | 18 | 6.5 | 78 |
| Other | 2011 | 15 | 5.4 | 50 |
| Other | 2009 | 5 | 5.2 | 13 |
| Other | 2012 | 14 | 5.1 | 42 |
| Other | 2010 | 11 | 4.0 | 22 |
| Injury | 2014 | 11 | 2.6 | 15 |
| Injury | 2012 | 5 | 2.6 | 6 |
| Injury | 2021 | 8 | 2.6 | 10 |
| Injury | 2022 | 17 | 2.5 | 22 |
| Injury | 2014 | 13 | 2.3 | 13 |
| Injury | 2016 | 192 | 2.2 | 211 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 181,974 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Baxter Healthcare Corp | 51 | 2013 | — |
| Abbott Laboratories | 30 | 2003 | — |
| Y | 28 | 1996 | — |
| ICU MEDICAL, INC. | 27 | 2025 | — |
| B.Braun Medical, Inc. | 22 | 2025 | — |
| Travenol Laboratories, S.A. | 21 | 1987 | — |
| Baxter Healthcare Corporation | 16 | 2025 | — |
| NEXUS MEDICAL, LLC | 14 | 2015 | — |
| HOSPIRA, INC. | 14 | 2017 | — |
| Quest Medical, Inc. | 12 | 2024 | — |
| Medtronic MINIMED | 12 | 2010 | — |
| Unomedical A/S | 12 | 2021 | — |
| Imed Corp. | 12 | 1995 | — |
| Medex, Inc. | 9 | 1998 | — |
| I-Flow Corp. | 9 | 1999 | — |
| Pharmacia Deltec, Inc. | 8 | 1994 | — |
| Churchill Medical Systems, Inc. | 7 | 2002 | — |
| TERUMO EUROPE N.V. | 7 | 2014 | — |
| C.R. Bard, Inc. | 6 | 2016 | — |
| Terumo Medical Corp. | 6 | 2001 | — |
| Quinton, Inc. | 4 | 1989 | — |
| Valleylab, Inc. | 4 | 1988 | — |
| AMSINO INTERNATIONAL, INC. | 4 | 2022 | — |
| CAIR LGL | 4 | 2017 | — |
| Critikon Company, LLC | 4 | 1987 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
PuraCath Firefly Needleless Connector IT (9005) · Puracath Medical, Inc.510(k) · 2026-02-12
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] · Np Medical510(k) · 2025-12-04
BD Alaris Pump Infusion Set · Carefusion (Bd)510(k) · 2025-10-30
EZ IV Administration Set · Epic Medical Pte. , Ltd.510(k) · 2025-08-29
SteadiSet infusion set · Tandem Diabetes Care510(k) · 2025-08-06
Sparta Infusion Set for Insulin · Deka Research and Development510(k) · 2025-08-01
Infusomat® Space Volumetric Infusion Pump Administration Sets · B.Braun Medical, Inc.510(k) · 2025-07-24
Clave Neutral-Displacement Needlefree Connectors · Icu Medical, Inc.510(k) · 2025-06-05
SteadiSet Infusion Set · Capillary Biomedical, LLC510(k) · 2025-05-09
JetCan® Pro Safety Huber Needle · Pfm Medical, Inc.510(k) · 2025-05-02
Solution Administration Sets · Baxter Healthcare Corporation510(k) · 2025-03-14
Intravascular Extension Sets and Accessories · Baxter Healthcare Corporation510(k) · 2025-02-28
Lyka® PORT Needle Free Access Device (4170Y) · Quest Medical, Inc.510(k) · 2024-12-18
Ecomed Disposable Administration Sets · Ecomed Solutions, LLC510(k) · 2024-09-20
I.V. Administration Set · Bq Plus Medical Co., Ltd.510(k) · 2024-08-22
Disposable infusion set with needle · Shandong Zhushi Pharmaceutical Group Co., Ltd.510(k) · 2024-05-10
Disposable Extension Set · Shandong Ande Healthcare Apparatus Co., Ltd.510(k) · 2024-04-12
Insignis Syringe Infusion System · Innovative Health Sciences, LLC510(k) · 2024-03-01
ResQ Administration Set · Q For Plastic Industries510(k) · 2024-01-03
Extension Set · Medcaptain Life Science Co., Ltd.510(k) · 2023-12-01
LILY Extension Tube and Needleless Connector · Lily Medical Corporation510(k) · 2023-11-09
ProSeal Closed System Administration Set · Epic Medical Pte. , Ltd.510(k) · 2023-11-03
BD Alaris Pump Infusion Sets · Care Fusion510(k) · 2023-07-21
Surflo Winged Infusion Set · Terumo Medical Products (Hangzhou) Co., Ltd.510(k) · 2023-06-23
Volumat Polyethylene I.V. Administration Set · Fresenius Kabi510(k) · 2023-06-16
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.