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

Nidacon International AB — Predicate Candidate Screening

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

78 daysmedian FDA review time

303 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K131145	PROINSERT	Nidacon International AB	2014-02-20	303
K092107	VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010	Nidacon International AB	2010-06-15	336
K023206	SPERM CRYOPROTEC	Nidacon International AB	2002-11-08	44
K022443	SPERMASSIST	Nidacon International AB	2002-08-28	34
K011607	SPERMCATCH	Nidacon International AB	2001-08-10	78
K012123	NIDOIL	Nidacon International AB	2001-08-03	28
K011606	PURESPERM BUFFER	Nidacon International AB	2001-07-12	49
K011346	READYSWIM	Nidacon International AB	2001-06-28	57
K002630	PURESPERM WASH	Nidacon International AB	2000-11-21	90
K002623	PURESPERM 40 AND PURESPERM 80	Nidacon International AB	2000-11-20	89
K984172	MODIFICATION OF PURESPERM	Nidacon International AB	1999-01-14	55
K980814	PURESPERM	Nidacon International AB	1998-06-23	112

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