FDA applicant

Althin Medical AB

Ronneby, SE7 decisions1999–20000 recalls

FDA records 7 decisions for Althin Medical AB (Ronneby, SE) from 1999 to 2000: 7 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FJI (Dialyzer, Capillary, Hollow Fiber). Its devices cite 8 predicates, 0 of them its own earlier devices. No 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 Althin Medical AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Althin Medical AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Althin Medical AB’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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Other applicant names beginning “Althin”

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

Althin Medical AB an Affiliate of Baxter Intl 27 Althin Biopharm, Inc. 1

Althin Medical AB

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Althin”