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

Polystan A/S — Predicate Candidate Screening

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

338 daysmedian FDA review time

942 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K023251	PEDIATRIC ARTERIAL CANNULA	Polystan A/S	2002-12-04	65	1
K013038	SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010	Polystan A/S	2002-08-14	338	0
K022281	SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045	Polystan A/S	2002-08-06	22	0
K980974	SAFE MINI	Polystan A/S	2000-10-13	942	0
K953976	SAFE MICRO	Polystan A/S	1997-02-04	531	0
K912082	SAFE II	Polystan A/S	1991-12-04	208	0

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