510(k) Report

FDA applicant

Gambro Renal Products

Lakewood, CO37 decisions2000–201462 recalls

FDA records 37 decisions for Gambro Renal Products (Lakewood, CO) from 2000 to 2014: 37 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and KPO (Dialysate Concentrate For Hemodialysis (Liquid…). Its devices cite 45 predicates, 22 of them its own earlier devices. 62 recalls are linked to its devices.

FDA’s records also spell it “Gambro Renal Products, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Gambro Renal Products’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2007: 42008: 22010: 32011: 22012: 22013: 12014: 2
2007high 4 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

4in 2026

2007: 22008: 22014: 82016: 22017: 42018: 32019: 32020: 172021: 52022: 82026 (partial year): 4
2007high 17 (2020) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Gambro Renal Products by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gambro Renal Products’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System18decisions
  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)6decisions
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve3decisions
  • FLDApparatus, Hemoperfusion, Sorbent3decisions
  • FIPSubsystem, Water Purification3decisions
  • MPBCatheter, Hemodialysis, Non-Implanted2decisions

Also: MSF (1), FJI (1).

Whose devices does it build on?

Its devices cite 45 predicates; 22 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 55 times; 22 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013448PrismasateGambro Renal Products · 20026cite it
  • K013724BicartGambro Renal Products · 20025cite it
  • K093608Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc. · 20105cite it
  • K010985Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10LGambro Renal Products · 20013cite it
  • K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 20043cite it
  • K003957Diaclear UltrafilterGambro Renal Products · 20013cite it

What has FDA decided for it lately?

  • K133807Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitGambro Renal Products, Inc. · 20141 recall
  • K131516Prismaflex System 7.10Gambro Renal Products, Inc. · 20144 recalls
  • K130039Revaclear 300 Dialyzer, Revaclear 400 DialyzerGambro Renal Products, Inc. · 20137 recalls
  • K113313Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc. · 2012
  • K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012
  • K110823PrismaflexGambro Renal Products, Inc. · 20119 recalls
  • K103832Phoenix Hemodialysis Delivery SystemGambro Renal Products, Inc. · 20112 recalls
  • K100451Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin MS-GDHC-1320 a; and…Gambro Renal Products, Inc. · 2010

All 24 as Gambro Renal Products →All 13 as Gambro Renal Products, Inc. →

What has been recalled?

62 recalls linked to its devices; the latest:

  • K042938PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without…Jan 6, 2026Class II
  • K041005PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without…Jan 6, 2026Class II
  • K080519PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without…Jan 6, 2026Class II
  • K042938PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without…Jan 6, 2026Class II
  • K130039Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal…Nov 23, 2022Class II
  • K130039Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by…Nov 23, 2022Class II

Other applicant names beginning “Gambro”

FDA records each applicant name separately; these may or may not be the same firm.

Gambro, Inc. 87Gambro Healthcare 13Gambro-Hospal, Inc. 3Gambro Bct, Inc. 2Gambro Renal Care Products 2Gambro Services, Inc. 1Gambro-Hosp-Cobe, Inc. 1