Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Althin Medical AB — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

169 daysmedian FDA review time
169 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K992564AF-180 HEMODIALYZERAlthin Medical AB2000-01-181690
K992566AF-150 HEMODIALYZERAlthin Medical AB2000-01-181690
K992573AF-220 HEMODIALYZERAlthin Medical AB2000-01-181690
K992563A-22 HEMODIALYZERAlthin Medical AB2000-01-181690
K992594A-15 HEMODIALYZERAlthin Medical AB1999-09-24520
K992565A-18 HEMODIALYZERAlthin Medical AB1999-09-23520
K990010ALTHIN MEDICAL AB ALTRACART IIAlthin Medical AB1999-04-151010

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda