Device type
Set, Administration, Intravascular
Product code FPA · Class II · 21 CFR 880.5440 · General Hospital
Recent 510(k)s
Oct 22, 2026
K260261
Gravity Blood Sets with 200µm Filter
B.Braun Medical, Inc.
- FPA
- Class II
Sep 11, 2026
K254123
Ecomed Disposable Administration Sets
Ecomed Solutions, LLC
- FPA
- Class II
Recent recalls
Oct 28, 2026
Z-0193-2027
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
B Braun Medical Inc
- FPA
- Class II
- Ongoing
Sep 23, 2026
Z-3080-2026
BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015…
BD SWITZERLAND SARL
- FPA
- Class I
- Ongoing
Sep 23, 2026
Z-3156-2026
Plum administration sets
ICU Medical, Inc.
- FPA
- Class II
- Ongoing
Sep 23, 2026
Z-3158-2026
Oncology sets with drip chambers
ICU Medical, Inc.
- FPA
- Class II
- Ongoing
Sep 23, 2026
Z-3160-2026
IV Sets with drip chambers
ICU Medical, Inc.
- FPA
- Class II
- Ongoing
Sep 9, 2026
Z-3089-2026
Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
B Braun Medical Inc
- FPA
- Class II
- Ongoing