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

GQS — Predicate Candidate Screening

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

91 daysmedian FDA review time

374 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K093415	D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICA	Diagnostic Hybrids, Inc.	2009-12-23	51
K943557	IMAGEN	Dako Diagnostics , Ltd.	1995-01-09	171
K905385	P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN	Virion (U.S.), Inc.	1991-03-21	111
K884194	PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT	Baxter Diagnostics, Inc.	1988-11-22	47
K884193	PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT	Baxter Diagnostics, Inc.	1988-11-22	47
K871234	ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1	Microscan Div. Baxter Healthcare Corp.	1987-06-26	91
K871228	ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2	Microscan Div. Baxter Healthcare Corp.	1987-06-26	91
K871232	ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3	Microscan Div. Baxter Healthcare Corp.	1987-06-26	91
K843665	PARAINFLUENZA 1	Institute Virion , Ltd.	1985-09-26	374
K843667	PARAINFLUENZA 3	Institute Virion , Ltd.	1985-09-26	374
K802935	PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR	Orion Diagnostica, Inc.	1980-12-31	42

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