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

GNW — Predicate Candidate Screening

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

74 daysmedian FDA review time

214 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K092882	D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICAT	Diagnostic Hybrids, Inc.	2009-10-21	33	0
K092300	MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & I	Diagnostic Hybrids, Inc.	2009-08-28	30	0
K081746	D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT	Diagnostic Hybrids, Inc.	2008-12-23	187	0
K061101	D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT	Diagnostic Hybrids, Inc.	2006-11-20	214	0
K022713	DFA RESPIRATORY VIRUS SCREENING & ID KIT	Diagnostic Hybrids, Inc.	2002-12-18	126	0
K003204	BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT	Intracel Corp.	2000-11-07	25	0
K974302	LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B	Light Diagnostics	1998-04-08	142	2
K973954	IMAGEN RESPIRATORY SCREEN	Dako Diagnostics , Ltd.	1997-12-22	74	0
K962037	IMAGEN RESPIRATORY SCREEN	Dako Diagnostics , Ltd.	1996-12-26	216	0
K942172	INFLUENZA A ANTIGEN TEST	Neogenex	1994-07-06	62	0
K942174	INFLUENZA B ANITGEN TEST	Neogenex	1994-06-30	56	0
K913351	INFLUENZA MAB TEST/INFLUENZA A TEST	Gull Laboratories, Inc.	1991-12-17	144	0
K913214	INFLUENZA MAB TEST/INFLUENZA B TEST	Gull Laboratories, Inc.	1991-12-13	147	0
K896635	VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY	Baxter Healthcare Corp	1990-02-02	72	0
K872694	YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN	Sita, Inc.	1987-09-18	73	0
K872693	INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN	Sita, Inc.	1987-09-18	73	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