FDA applicant
Gambro Healthcare
FDA records 13 decisions for Gambro Healthcare (Lakewood, CO) from 1996 to 2000: 13 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FIP (Subsystem, Water Purification). Its devices cite 8 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Gambro Healthcare’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Gambro Healthcare since 2007.
Recalls per year
1in 2014
Class I Class II/III not classified
Planning a device like Gambro Healthcare’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Gambro”
FDA records each applicant name separately; these may or may not be the same firm.