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

NSU — Predicate Candidate Screening

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

114 daysmedian FDA review time

255 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K163652	ePlex Instrument	Genmark Diagnostics, Incorporated	2017-06-09	168	0
K143178	FilmArray 2.0 System	Biofire Diagnostics, LLC	2015-01-30	87	1
K133849	VANTERA CLINICAL ANALYZER	Liposcience	2014-10-22	307	0
K141220	APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WIT	Thermo Fisher Scientific (Life Technologies Holdin	2014-05-22	10	0
K133302	FLEXMAP 3D	Luminex Corp.	2014-01-10	77	0
K121399	LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SP	Luminex Corp.	2013-01-09	245	0
K110786	ESENSOR WARFARIN SENSITIVITY SALIVA TEST	GenMark Diagnostics, Inc.	2011-12-02	255	0
K093128	ILLUMINA BEADXPRESS SYSTEM	Illumina, Inc.	2010-04-28	208	0
K082562	APPLIED BIOSYSTEMS 7500 FAST DX	Applied Biosystems, Inc.	2008-09-30	26	0
K080995	MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATI	Affymetrix, Inc.	2008-07-30	114	0
K073506	LUMINEX LX 100/200 INSTRUMENT	Luminex Corp.	2008-03-07	85	0
K070597	VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST,	Nanosphere, Inc.	2007-10-11	223	0
DEN040012	AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM	Affymetrix, Inc.	2004-12-23	50	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