510(k) Report

FDA applicant

Gambro Renal Care Products

Lakewood, CO2 decisions1999–20031 recall

FDA records 2 decisions for Gambro Renal Care Products (Lakewood, CO) from 1999 to 2003: 2 510(k) clearances. All are in product code KDI (Dialyzer, High Permeability With Or Without…). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

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 Care Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gambro Renal Care Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 0 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.

  • K030592Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products · 20036cite it
  • K993064Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 19992cite it

What has FDA decided for it lately?

  • K030592Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products · 2003
  • K993064Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 19991 recall

All 2 as Gambro Renal Care Products →

What has been recalled?

1 recall linked to its devices; the latest:

  • K010805Prisma continuous renal replacement system.Aug 16, 2005

Other applicant names beginning “Gambro”

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

Gambro, Inc. 87Gambro Renal Products 37Gambro Healthcare 13Gambro-Hospal, Inc. 3Gambro Bct, Inc. 2Gambro Services, Inc. 1Gambro-Hosp-Cobe, Inc. 1