# Cobe Renal Care, Inc.

- Location (FDA's records): Lakewood, CO
- FDA decisions: 14 (1994–1997): 14 510(k) clearances
- Product codes: KDI (8), FJG (2), FJI (2), KDL (1), MQS (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 11 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- C.G.H. Medical, Inc.: 1 (https://510kreport.com/company/cgh-medical)
- Gambro, Inc.: 1 (https://510kreport.com/company/gambro)

## Firms that cite its devices most
- Nxstage Medical, Inc.: 2 (https://510kreport.com/company/nxstage-medical)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Gambro Healthcare: 2 (https://510kreport.com/company/gambro-healthcare)
- Edwards Lifesciences Services GmbH: 1 (https://510kreport.com/company/edwards-lifesciences-services)
- Sorin Group Italia S.R.L.: 1 (https://510kreport.com/company/sorin-group-italia)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Gambro, Inc.: 1 (https://510kreport.com/company/gambro)
- Transvivo, Inc.: 1 (https://510kreport.com/company/transvivo)

## Its most-cited devices
- K946279: Prisma CFM (Continuous Fluid Management System) (1997), cited by 8
- K955592: Cobe Centrysystem 14 Pes Hemodialyzers (1997), cited by 2
- K951311: Gambro HC 14R Hemoconcentrator (1996), cited by 1

## Recent decisions
- K955497: Gambro FH 22H Fiber Hemofltr/Prisma FH 22H Blood Tubing/Hemofltr Set (Sep 25, 1997)
- K955592: Cobe Centrysystem 14 Pes Hemodialyzers (Apr 30, 1997)
- K955487: Gambro Polyflux 14, 17, & 21 Hemodialyzers (Apr 18, 1997)
- K946279: Prisma CFM (Continuous Fluid Management System) (Feb 10, 1997)
- K954003: Cobe Hemodynamic Recirculation Monitor (Feb 6, 1997)
- K960474: Cobe Centrysystem 600 HG Hemodialyzers (Aug 14, 1996)
- K944436: Cobe Centrysystem CS 200 Dialyzer (Jan 29, 1996)
- K951311: Gambro HC 14R Hemoconcentrator (Jan 11, 1996)

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