# Gambro, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 87 (1976–2009): 87 510(k) clearances
- Names in FDA's records: Gambro, Inc. (86); Gambro (1)
- Product codes: KDI (15), FJI (10), KOC (9), FJG (7), FKP (6), CBK (2), DTW (2), FII (2), HRX (2), FHS (2), DWC (2), FJK (2)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 20 (0 its own)
- Recalls linked to its devices: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gambro Healthcare: 2 (https://510kreport.com/company/gambro-healthcare)
- Cybernius Medical, Ltd.: 1 (https://510kreport.com/company/cybernius-medical)
- Cobe Renal Care, Inc.: 1 (https://510kreport.com/company/cobe-renal-care)

## Firms that cite its devices most
- Gambro Renal Products: 5 (https://510kreport.com/company/gambro-renal-products)
- Aksys, Ltd.: 3 (https://510kreport.com/company/aksys)
- Nxstage Medical, Inc.: 2 (https://510kreport.com/company/nxstage-medical)
- Fresenius Medical Care North America, Design Cente: 1 (https://510kreport.com/company/fresenius-medical-care-north-america-design-cente)
- Gambro Healthcare: 1 (https://510kreport.com/company/gambro-healthcare)
- Redsense Medical AB: 1 (https://510kreport.com/company/redsense-medical)
- Bl Healthcare, Inc.: 1 (https://510kreport.com/company/bl-healthcare)
- Edwards Lifesciences Services GmbH: 1 (https://510kreport.com/company/edwards-lifesciences-services)

## Its most-cited devices
- K902481: Gambro Alwall GFS Plus 11, 16 & 20 Hollow Fiber (1990), cited by 4
- K032431: Prisma M60/M100 Sets (2003), cited by 4
- K873155: Gambro Bicart System (1987), cited by 3
- K070643: Phoenix Hemodialysis Delivery System, Version 3.35 (2007), cited by 2
- K811678: Gambro Water Purification Monitor WRD (1981), cited by 2
- K810127: Gambro Bicarbonate Module, BCM-10 (1981), cited by 1

## Recent decisions
- K083158: Exalis, Software Version 1.15 (Jun 5, 2009)
- K072093: Prismaflex System, Version 3.20 (Feb 1, 2008)
- K070643: Phoenix Hemodialysis Delivery System, Version 3.35 (Nov 2, 2007)
- K032431: Prisma M60/M100 Sets (Sep 15, 2003)
- K896758: Gambro Bicarbonate Monitor BCM 10-3 (Sep 28, 1990)
- K896757: Gambro AK-10 Dialysis System for High Flows (Aug 30, 1990)
- K902481: Gambro Alwall GFS Plus 11, 16 & 20 Hollow Fiber (Jul 27, 1990)
- K900918: Gambro Lundia IC-6H Parallel Plate Dialyzer (Jul 16, 1990)

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