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

JTR — Predicate Candidate Screening

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

26 daysmedian FDA review time

46 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K871121	PROTECT T.M.	Pro-Lab, Inc.	1987-04-14	26	0
K862914	FEKAL CHECK PARASITOLOGY CONTROL SLIDE	Trend Scientific, Inc.	1986-09-16	46	0
K861022	KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS	Micro-Bio-Logics	1986-04-04	17	18
K855198	INDI KWIK (TM) CO/TWO KIT	Micro-Bio-Logics	1986-01-14	18	0
K842579	B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS	Biological & Environmental Control Laboratories	1984-07-27	24	1
K842129	LYFO-DISK MICROORGANISMS	Micro-Bio-Logics	1984-07-03	35	0
K831653	LYOPHILIZED MICROORGANISMS	Austin Biological Laboratories	1983-07-28	66	0
K830133	Q-CHECK CULTI-LOOPS	Lab Ability, Inc.	1983-02-09	27	0
K822954	MICROTECH BACTERIAL CONTROLS	Universal Micro Reference Laboratory	1982-11-16	43	0
K821660	BIO-CHECK GRAM STAIN CONTROL	American Scientific Products	1982-06-25	21	0
K820064	SUSCEPTROL	American Type Culture Collection	1982-01-28	17	0
K812698	GC DISK	Remel Co.	1981-10-06	14	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