# Cardinal Health, Alaris Products

- Location (FDA's records): San Diego, CA
- FDA decisions: 9 (2005–2007): 9 510(k) clearances
- Product codes: FPA (2), FRN (2), FLL (1), LHI (1), BRZ (1), FMG (1), FMF (1)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 17 (1 its own)
- Recalls linked to its devices: 33 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Y: 3 (https://510kreport.com/company/y)
- Quality System Consulting: 1 (https://510kreport.com/company/quality-system-consulting)
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)
- Imed Corp.: 1 (https://510kreport.com/company/imed)
- B. Braun of America, Inc.: 1 (https://510kreport.com/company/b-braun-of-america)
- Ivac Medical Systems: 1 (https://510kreport.com/company/ivac-medical-systems)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Elcam Medical Acal: 1 (https://510kreport.com/company/elcam-medical-acal)

## Firms that cite its devices most
- Care Fusion: 3 (https://510kreport.com/company/care-fusion)
- Yukon Medical, LLC: 2 (https://510kreport.com/company/yukon-medical)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Us Fusion, LLC. Dba Truecare Biomedix-USA: 1 (https://510kreport.com/company/us-fusion-dba-truecare-biomedix-usa)
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)
- American I.V. Products, Inc.: 1 (https://510kreport.com/company/american-iv-products)

## Its most-cited devices
- K061285: Smartsite Needle Free Valve Administration Sets (2006), cited by 4
- K053049: Alaris Safety Male Luer (2006), cited by 3
- K052790: Smartsite Vented Vial  Access Device, Model TBD (2005), cited by 3
- K051641: Alaris System PC Unit, Model 8001 (2005), cited by 2
- K050230: Turbo Temp Trio (2005), cited by 2
- K071108: Texium Syringe (2007), cited by 2

## Recent decisions
- K071400: Smartsite Stopcock (Dec 14, 2007)
- K071108: Texium Syringe (May 24, 2007)
- K061285: Smartsite Needle Free Valve Administration Sets (Jul 26, 2006)
- K053049: Alaris Safety Male Luer (Jan 12, 2006)
- K052790: Smartsite Vented Vial  Access Device, Model TBD (Dec 23, 2005)
- K051641: Alaris System PC Unit, Model 8001 (Oct 20, 2005)
- K050115: Blood Hand Pump Administration Set (Apr 1, 2005)
- K043590: SE Infusion System with MMS (Mar 25, 2005)

Source page: https://510kreport.com/company/cardinal-health-alaris-products