FDA applicant
Althin Medical AB an Affiliate of Baxter Intl
FDA records 27 decisions for Althin Medical AB an Affiliate of Baxter Intl (Miami Lakes, FL) from 1991 to 1999: 27 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FJI (Dialyzer, Capillary, Hollow Fiber). Its devices cite 14 predicates, 6 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Althin Medical AB an Affiliate of Baxter Intl’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Althin Medical AB an Affiliate of Baxter Intl since 2007.
Recalls per year
1in 2011
Class I Class II/III not classified
Planning a device like Althin Medical AB an Affiliate of…’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 “Althin”
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