# Care Fusion

- Location (FDA's records): Vernon Hills, IL
- FDA decisions: 34 (2010–2024): 34 510(k) clearances
- Product codes: FPA (6), HRX (4), DWM (4), PNG (4), KNW (2), CBK (2), CAF (2), NDN (2), ONB (1), LHI (1), CCK (1), BZE (1)
- 510(k) review time since 2016: median 207 days, against 243 for FDA's reviews in the same codes and years (3 of 10 faster)
- Predicates its devices cite: 76 (17 its own); citations of its devices by later devices: 51 (17 its own)
- Recalls linked to its devices: 23 (16 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- C.R. Bard, Inc.: 6 (https://510kreport.com/company/cr-bard)
- Cardinalhealth: 5 (https://510kreport.com/company/cardinalhealth)
- Cardinal Health, Inc.: 4 (https://510kreport.com/company/cardinal-health)
- Kyphon, Inc.: 4 (https://510kreport.com/company/kyphon)
- Medegen Medical Manufacturing Services: 3 (https://510kreport.com/company/medegen-medical-manufacturing-services)
- Cardinal Health, Alaris Products: 3 (https://510kreport.com/company/cardinal-health-alaris-products)
- Allegiance Healthcare Corp.: 3 (https://510kreport.com/company/allegiance-healthcare)
- Salter Labs: 3 (https://510kreport.com/company/salter-labs)

## Firms that cite its devices most
- Osseon Therapeutics, Inc.: 2 (https://510kreport.com/company/osseon-therapeutics)
- Zhejiang Curaway Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/zhejiang-curaway-medical-technology)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Medax Srl Unipersonale: 2 (https://510kreport.com/company/medax-unipersonale)
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- Carefusion, Inc.: 1 (https://510kreport.com/company/carefusion)
- Cair Lgl: 1 (https://510kreport.com/company/cair-lgl)
- Ushare Medical, Inc.: 1 (https://510kreport.com/company/ushare-medical)

## Its most-cited devices
- K132413: MZ1000 (2013), cited by 6
- K140831: Maxzero Extension Set with Needless Connector (2014), cited by 6
- K141552: Achieve Programmable Auomated Biopsy Systems (2014), cited by 5
- K103064: Avamax Vertebral Balloon (2011), cited by 4
- K093463: Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 (2010), cited by 4
- K171531: Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle (2017), cited by 3

## Recent decisions
- K233021: BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device (Mar 6, 2024)
- K231888: BD Texium™ Needle-Free Syringe (Sep 25, 2023)
- K221327: BD Alaris™ Pump Infusion Sets (Jul 21, 2023)
- K221319: BD Alaris™ Pump Epidural Infusion Set (Jul 21, 2023)
- K223101: BD Secondary Infusion Set (May 12, 2023)
- K223088: BD SmartSite™ Needle-Free Connector (Apr 7, 2023)
- K223076: BD Texium™ Closed Male Luer (Mar 24, 2023)
- K201155: PleurX Peritoneal Catheter System (Oct 21, 2020)

Source page: https://510kreport.com/company/care-fusion