# Icu Medical, Inc.

- Location (FDA's records): San Clemente, CA
- FDA decisions: 72 (1984–2026): 72 510(k) clearances
- Names in FDA's records: Icu Medical, Inc. (66); Icu Medical (5); ICU Medical (1)
- Product codes: FPA (27), FMG (5), ONB (4), FMI (4), FRN (4), FMF (4), PHC (3), LHI (2), QBP (2), DQO (2), KNT (2), FEG (1)
- 510(k) review time since 2016: median 261 days, against 221 for FDA's reviews in the same codes and years (4 of 12 faster)
- Predicates its devices cite: 68 (37 its own); citations of its devices by later devices: 75 (37 its own)
- Recalls linked to its devices: 376 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hospira, Inc.: 5 (https://510kreport.com/company/hospira)
- Abbott Laboratories: 4 (https://510kreport.com/company/abbott-laboratories)
- B.Braun Medical, Inc.: 3 (https://510kreport.com/company/b-braun-medical)
- Baxter Healthcare Corp: 3 (https://510kreport.com/company/baxter-healthcare)
- Excelsior Medical Corp.: 2 (https://510kreport.com/company/excelsior-medical)
- Laboratorios Grifols, S.A.: 1 (https://510kreport.com/company/laboratorios-grifols)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Q Core Medical, Ltd.: 1 (https://510kreport.com/company/q-core-medical)

## Firms that cite its devices most
- Victus, Inc.: 6 (https://510kreport.com/company/victus)
- B.Braun Medical, Inc.: 3 (https://510kreport.com/company/b-braun-medical)
- Kendall: 2 (https://510kreport.com/company/kendall)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Np Medical, Inc.: 2 (https://510kreport.com/company/np-medical)
- Medegen Medical Manufacturing Services: 2 (https://510kreport.com/company/medegen-medical-manufacturing-services)
- Syncro Medical Innovations, Inc.: 1 (https://510kreport.com/company/syncro-medical-innovations)
- Cardinal Health, Alaris Products: 1 (https://510kreport.com/company/cardinal-health-alaris-products)

## Its most-cited devices
- K970855: Clave Connector (1997), cited by 15
- K915571: Clave Connector (1992), cited by 7
- K964435: Primary IV Set (1997), cited by 5
- K070532: Spiros (2007), cited by 4
- K941190: Clave Needle-Less Connector Open Extension Set (1995), cited by 4
- K915171: Lopez Valve TM  II (1992), cited by 4

## Recent decisions
- K262532: NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (Sep 18, 2026)
- K252130: LifeShield Infusion Safety Software Suite (Apr 2, 2026)
- K252006: OTTO™ Disinfecting Cap (Mar 27, 2026)
- K251980: ClaveQS™ Bag (Mar 20, 2026)
- K250616: Clave™ Neutral-Displacement Needlefree Connectors (Jun 5, 2025)
- K242114: Plum Solo™ Precision IV Pump (Apr 2, 2025)
- K242117: LifeShield Infusion Safety Software Suite (Apr 2, 2025)
- K242115: Plum Duo™ Precision IV Pump (Apr 2, 2025)

Source page: https://510kreport.com/company/icu-medical