Atlas FDA

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

NUA — Predicate Candidate Screening

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

232 daysmedian FDA review time
416 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K163347xTAG Cystic Fibrosis 39 Kit v2Luminex Molecular Diagnostics, Inc.2016-12-15170
K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software Luminex Molecular Diagnostics, Inc.2016-12-15170
K083845XTAG CF60 KIT V2Luminex Molecular Diagnostics, Inc.2009-12-113520
K083846XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027Luminex Molecular Diagnostics, Inc.2009-09-012510
K083294VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLNanosphere, Inc.2009-07-242560
K090901ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FOsmetech Molecular Diagnostics2009-07-06960
K063787INPLEX CF MOLECULAR TESTThird Wave Technologies, Inc.2008-03-134480
K062028CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01Celera Diagnostics2007-09-074160
K060627TAG-IT CYSTIC FIBROSIS KITTm Bioscience Corporation2006-06-07900
K060543ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENClinical Micro Sensors, Inc.2006-03-28270
K051435ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 480Clinical Micro Sensors2006-01-192320
DEN050004TAG-IT CYSTIC FIBROSIS KITTm Bioscience Corporation2005-05-09340

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