# Gambro Renal Products

- Location (FDA's records): Lakewood, CO
- FDA decisions: 37 (2000–2014): 37 510(k) clearances
- Names in FDA's records: Gambro Renal Products (24); Gambro Renal Products, Inc. (13)
- Product codes: KDI (18), KPO (6), FJK (3), FLD (3), FIP (3), MPB (2), MSF (1), FJI (1)
- Predicates its devices cite: 45 (22 its own); citations of its devices by later devices: 55 (22 its own)
- Recalls linked to its devices: 62 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gambro, Inc.: 5 (https://510kreport.com/company/gambro)
- Gambro Renal Care Products: 4 (https://510kreport.com/company/gambro-renal-care-products)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- B.Braun Medical, Inc.: 2 (https://510kreport.com/company/b-braun-medical)
- Gambro Healthcare: 2 (https://510kreport.com/company/gambro-healthcare)
- C.G.H. Medical, Inc.: 1 (https://510kreport.com/company/cgh-medical)
- Medical Components, Inc.: 1 (https://510kreport.com/company/medical-components)
- Novex Pharma: 1 (https://510kreport.com/company/novex-pharma)

## Firms that cite its devices most
- Baxter Healthcare Corp: 8 (https://510kreport.com/company/baxter-healthcare)
- Fresenius Medical Care Renal Therapies Group, LLC: 3 (https://510kreport.com/company/fresenius-medical-care-renal-therapies-group)
- Mar Cor Purification, Inc.: 3 (https://510kreport.com/company/mar-cor-purification)
- Baxter Healthcare Corportation: 3 (https://510kreport.com/company/baxter-healthcare-corportation)
- B.Braun Medical, Inc.: 2 (https://510kreport.com/company/b-braun-medical)
- Nxstage Medical, Inc.: 2 (https://510kreport.com/company/nxstage-medical)
- B. Braun Medizintechnologie GmbH: 2 (https://510kreport.com/company/b-braun-medizintechnologie)
- Lauer Membran Wassertechnik GmbH: 1 (https://510kreport.com/company/lauer-membran-wassertechnik)

## Its most-cited devices
- K013448: Prismasate (2002), cited by 6
- K013724: Bicart (2002), cited by 5
- K093608: Gambro Water Purification Unit, Models Wro 300 and Wro 300 H (2010), cited by 5
- K010985: Gambro Polyflux  6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L (2001), cited by 3
- K041005: Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets (2004), cited by 3
- K003957: Diaclear Ultrafilter (2001), cited by 3

## Recent decisions
- K133807: Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control Unit (Mar 26, 2014)
- K131516: Prismaflex System 7.10 (Jan 3, 2014)
- K130039: Revaclear 300 Dialyzer, Revaclear 400 Dialyzer (May 2, 2013)
- K113313: Molecular Adsorbent Recirculating (Mars) (Dec 14, 2012)
- K120333: Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy (May 25, 2012)
- K110823: Prismaflex (Jun 17, 2011)
- K103832: Phoenix Hemodialysis Delivery System (May 20, 2011)
- K100451: Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin MS-GDHC-1320 a; and MS-GDHC-132 (Dec 21, 2010)

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