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

LIC — Predicate Candidate Screening

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

81 daysmedian FDA review time

172 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K921075	PHADEBACT MONOCLONAL GC TEST, MODIFICATION	Karo Bio Diagnostics AB	1992-05-22	84
K911430	IDEIA(TM) CHLAMYDIA, MODIFICATION	Novo Nordisk Diagnostics, Ltd.	1991-08-07	132
K880076	G-MARK	Bainbridge Laboratories, Inc.	1988-07-01	172
K874078	MERITEC(TM)-GC	Meridian Diagnostics, Inc.	1987-12-09	64
K871105	THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE	New Horizons Diagnostics Co.	1987-05-13	55
K851650	PHADEBACT MONOCLONAL GC OMNI TEST	Pharmacia, Inc.	1985-07-12	81
K850351	PHADEBACT MONOCLONAL GC TEST	Pharmacia, Inc.	1985-03-13	44
K821362	IMPROVED GONO GEN	New Horizons Diagnostics Co.	1982-08-04	89
K820007	NEISSERIA GONORRHOEAE TEST	New Horizons Diagnostics Co.	1982-01-29	25

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