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

Biostar, Inc. — Predicate Candidate Screening

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

198 daysmedian FDA review time

421 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K991829	CDTOX A OIA	Biostar, Inc.	1999-11-02	158	0
K991828	STREP B OIA	Biostar, Inc.	1999-08-19	83	0
K981651	AB FLU OIA	Biostar, Inc.	1998-11-25	198	0
K962060	STREP A OIA MAX	Biostar, Inc.	1997-07-23	421	1
K951010	CHLAMYDIA OIA	Biostar, Inc.	1995-10-07	215	2
K936112	STREP B OIA	Biostar, Inc.	1994-07-06	195	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