Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GNA — Predicate Candidate Screening

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

162 daysmedian FDA review time

308 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K071799	MODIFICATION TO BIOSTAR OIA SHIGATOX	Iverness Medical Professional Diagnostics	2007-10-02	92	0
K031367	DUOPATH VEROTOXINS GLISA TEST	Emd Chemicals, Inc.	2004-01-23	268	0
K993401	DRYSPOT E.COLI 0157 KIT	Oxoid , Ltd.	2000-02-28	143	0
K981734	VTEC-RPLA SEIKEN	Denka Seiken'S	1998-09-22	127	0
K962028	WELLCOLEX E-COLI OI57 ZC60	Murex Diagnostics, Inc.	1996-11-01	162	0
K953362	PREMIER EHEC	Meridian Diagnostics, Inc.	1995-11-14	120	2
K950167	PREMIER EHEC	Meridian Diagnostics, Inc.	1995-04-14	87	0
K933457	RIM E.COLI 0157:H7 LATEX TEST	Remel Co.	1994-04-20	280	0
K903714	E. COLI 0157 LATEX TEST	Pro-Lab, Inc.	1991-01-24	163	0
K884026	ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT	Oxoid U.S.A., Inc.	1989-02-03	133	0
K874288	PHADEBACT ETEC-LT TEST	Pharmacia, Inc.	1988-09-02	318	0
K855234	DIAGNOSTIC REAGENT VET-RPLA	Oxoid U.S.A., Inc.	1986-11-04	308	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