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

OOI — Predicate Candidate Screening

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

88 daysmedian FDA review time

249 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243922	Revogene	Meridian Bioscience, Inc.	2025-03-20	90	0
K222779	Revogene	Meridian Bioscience, Inc.	2023-01-26	134	0
K220480	Revogene	Meridian Bioscience, Inc.	2022-07-11	143	0
K170558	revogene	Genepoc, Inc.	2017-05-25	90	0
K161495	ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24	Luminex Corporation	2016-06-30	29	2
K160517	ARIES System	Luminex Corporation	2016-04-12	48	2
K151917	ARIES System	Luminex Corporation	2015-10-06	85	1
K151690	Alere i Instrument, Alere i Influenza A & B, Alere i Strep A	Alere Scarborough, Inc.	2015-07-16	23	0
K140447	BD VIPER LT SYSTEM	Becton, Dickinson and Company	2014-05-20	88	2
K123955	QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT	Life Technologies Corporation	2013-03-08	77	0
K113319	ROTOR-GENE Q MDX	QIAGEN GmbH	2012-02-06	88	0
K102314	3M INTEGRATED CYCLER (110V) & (220V)	Focus Diagnostics, Inc.	2010-10-29	74	0
K093383	NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR	bioMerieux, Inc.	2010-07-06	249	1
K092705	ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES)	Abbott Molecular, Inc.	2010-05-28	267	7

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