Atlas FDA

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

Centers for Disease Control and Prevention · Predicate Candidate Screening

30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

42 daysmedian FDA review time
203 days90th percentile
29clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260812Francisella tularensis Real-time PCR AssayCenters for Disease Control and Prevention2026-03-30170
K252072Francisella tularensis Real-time PCR assayCenters for Disease Control and Prevention2025-09-30910
K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel:Centers for Disease Control and Prevention2025-07-112680
K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel:Centers for Disease Control and Prevention2025-03-14840
K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel,Centers for Disease Control and Prevention2024-05-21290
K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention2022-08-3060
K221834Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention2022-06-2410
K221658Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention2022-06-1020
K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel,Centers for Disease Control and Prevention2020-03-10251
K192871B. anthracis Real-time PCR AssayCenters for Disease Control and Prevention2019-11-07300
K190302CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel,Centers for Disease Control and Prevention2019-03-27430
DEN070001NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SETCenters for Disease Control and Prevention2018-09-210
K181205Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention2018-09-201360
K172091CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel,Centers for Disease Control and Prevention2017-08-09290
K141859CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL,Centers for Disease Control and Prevention2014-08-01220
K140857INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUCenters for Disease Control and Prevention2014-04-25220
K140851INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TICenters for Disease Control and Prevention2014-04-25220
K132508CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and Prevention2013-09-23420
DEN130005QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MCenters for Disease Control and Prevention2013-08-08720
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
DEN120012CDC DENV-1-4 REAL TIME RT-PCT ASSAYCenters for Disease Control and Prevention2012-05-24730
K111507CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and Prevention2011-08-23830
K101564CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANELCenters for Disease Control and Prevention2010-06-22180
K080570CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHCenters for Disease Control and Prevention2008-09-302140
DEN060008INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMERCenters for Disease Control and Prevention2006-02-0370
K993633SYNTHETIC VDRL ANTIGENCenters for Disease Control and Prevention2000-02-231190
K820945SERA FOR ANTINUCLEAR ANTIBODIESCenters for Disease Control and Prevention1982-10-262030
K812007LEGIONELLA INDIRECT FLUOR. ANTIBODYCenters for Disease Control and Prevention1981-09-08540
K812006LEGIONELLA DIRECT FLUORESCENT ANTIBODYCenters for Disease Control and Prevention1981-09-08540

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