Atlas FDA

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

OQW — Predicate Candidate Screening

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

79 daysmedian FDA review time
125 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K132237PRODESSE PROFAST+ ASSAYGen-Probe Prodesse, Inc.2013-08-26390
K130551CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and Prevention2013-05-22790
K123905CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and Prevention2013-01-14260
K120911XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)Cepheid2012-05-18530
K111778JBAIDS INFLUENZA A SUBTYPING KITU.S Army Medical Materiel Development Activity2011-09-13820
K111507CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and Prevention2011-08-23830
K103766XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, Cepheid2011-04-211191
K101855PROFAST+ ASSAYGen-Probe Prodesse, Inc.2010-07-23220
K101564CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANELCenters for Disease Control and Prevention2010-06-22180
K100148SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500Focus Diagnostics, Inc.2010-05-241250

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