# Gambro Renal Care Products

- Location (FDA's records): Lakewood, CO
- FDA decisions: 2 (1999–2003): 2 510(k) clearances
- Product codes: KDI (2)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gambro Healthcare: 3 (https://510kreport.com/company/gambro-healthcare)
- Althin Medical AB an Affiliate of Baxter Intl: 1 (https://510kreport.com/company/althin-medical-ab-an-affiliate-of-baxter-intl)
- Gambro, Inc.: 1 (https://510kreport.com/company/gambro)

## Firms that cite its devices most
- Gambro Renal Products: 4 (https://510kreport.com/company/gambro-renal-products)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Edwards Lifesciences Services GmbH: 1 (https://510kreport.com/company/edwards-lifesciences-services)
- Bellco Srl: 1 (https://510kreport.com/company/bellco)

## Its most-cited devices
- K030592: Gambro Polyflux, Model 140H, 170H, 210H (2003), cited by 6
- K993064: Prisma CFM (Continuous Fluid Management System) (1999), cited by 2

## Recent decisions
- K030592: Gambro Polyflux, Model 140H, 170H, 210H (May 23, 2003)
- K993064: Prisma CFM (Continuous Fluid Management System) (Oct 6, 1999)

Source page: https://510kreport.com/company/gambro-renal-care-products