Atlas FDA

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

Coapt Systems, Inc. — Predicate Candidate Screening

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

41 daysmedian FDA review time
242 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K083783VF LIQUIGELCoapt Systems, Inc.2009-09-112660
K080956MODIFICATION TO VF GEL PLUSCoapt Systems, Inc.2008-04-25220
K071663VF GEL PLUSCoapt Systems, Inc.2008-02-152420
K060248ULTRATINE TRANSBLEPHCoapt Systems, Inc.2006-06-121320
K060249ULTRATINE FOREHEADCoapt Systems, Inc.2006-06-121320
K060828MODIFICATION TO ENDOTINE RIBBONCoapt Systems, Inc.2006-04-19230
K051415ENDOTINE RIBBONCoapt Systems, Inc.2005-06-23220
K050611ENDOTINE RIBBONCoapt Systems, Inc.2005-04-06280
K042796ENDOTINE TRANSBLEPH 3.0/3.5 DEVICECoapt Systems, Inc.2004-11-05290
K041835ENDOTINE MIDFACE B 4.5 DEVICECoapt Systems, Inc.2004-09-28830
K042078ENDOTINE FOREHEAD TRIPLE DEVICECoapt Systems, Inc.2004-08-27250
K040740ENDOTINE TRANSBLEPH DEVICECoapt Systems, Inc.2004-05-10490
K033524COAPT ENDOTINE CHIN 3.5 DEVICECoapt Systems, Inc.2003-12-18410
K032698COAPT ENDOTINE MIDFACE-ST 4.5 DEVICECoapt Systems, Inc.2003-10-23510
K032770ENDOTINE FOREHEAD DEVICECoapt Systems, Inc.2003-10-08300
K023922COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197Coapt Systems, Inc.2002-12-20250
K014153COAPT SYSTMES ENDOTINE DEVICECoapt Systems, Inc.2002-03-15870

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