# Gambro Healthcare

- Location (FDA's records): Lakewood, CO
- FDA decisions: 13 (1996–2000): 13 510(k) clearances
- Product codes: KDI (7), FIP (2), FKT (1), LFP (1), MSF (1), KMF (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 24 (1 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cobe Renal Care, Inc.: 2 (https://510kreport.com/company/cobe-renal-care)
- Gambro, Inc.: 1 (https://510kreport.com/company/gambro)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- C.G.H. Medical, Inc.: 1 (https://510kreport.com/company/cgh-medical)
- Gambro-Hospal, Inc.: 1 (https://510kreport.com/company/gambro-hospal)
- Osmonics, Inc.: 1 (https://510kreport.com/company/osmonics)

## Firms that cite its devices most
- Chf Solutions, Inc.: 4 (https://510kreport.com/company/chf-solutions)
- Gambro Renal Care Products: 3 (https://510kreport.com/company/gambro-renal-care-products)
- Vascular Solutions, Inc.: 2 (https://510kreport.com/company/vascular-solutions)
- Gambro, Inc.: 2 (https://510kreport.com/company/gambro)
- Gambro Renal Products: 2 (https://510kreport.com/company/gambro-renal-products)
- Lauer Membran Wassertechnik GmbH: 1 (https://510kreport.com/company/lauer-membran-wassertechnik)
- Edwards Lifesciences Services GmbH: 1 (https://510kreport.com/company/edwards-lifesciences-services)
- Nephros, Inc.: 1 (https://510kreport.com/company/nephros)

## Its most-cited devices
- K981681: Prisma CFM (Continuous Fluid Management System) (1998), cited by 7
- K982414: Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters (1999), cited by 5
- K974899: Gambro Central Water Treatment System CWP 100 - Wro H (1998), cited by 5
- K980386: Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22 (B22,B22/B, & B22/0) (1999), cited by 2
- K982818: Hospal Tipstop (1998), cited by 2
- K994390: Gambro Polyflux 17R, Capillary Dialyzer/ Filter (2000), cited by 1

## Recent decisions
- K994390: Gambro Polyflux 17R, Capillary Dialyzer/ Filter (Oct 26, 2000)
- K990039: Gambro DQM 200 (Jan 27, 2000)
- K982413: Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/Filters (Apr 21, 1999)
- K982414: Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters (Mar 26, 1999)
- K980386: Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22 (B22,B22/B, & B22/0) (Feb 24, 1999)
- K982760: Cobe C Hemodialysis Delivery System , Cobe Cartridge Blood Tubing Set (Nov 4, 1998)
- K982818: Hospal Tipstop (Oct 21, 1998)
- K974899: Gambro Central Water Treatment System CWP 100 - Wro H (Sep 23, 1998)

Source page: https://510kreport.com/company/gambro-healthcare