FDA applicant
Gambro, Inc.
FDA records 87 decisions for Gambro, Inc. (Mchenry, IL) from 1976 to 2009: 87 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FJI (Dialyzer, Capillary, Hollow Fiber). Its devices cite 4 predicates, 0 of them its own earlier devices. 20 recalls are linked to its devices.
FDA’s records also spell it “Gambro”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Gambro, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Gambro, Inc.’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.