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

Cormatrix Cardiovascular, Inc. — Predicate Candidate Screening

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

106 daysmedian FDA review time
189 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix CoCormatrix Cardiovascular, Inc.2018-10-101740
K152127CorMatrix TykeCormatrix Cardiovascular, Inc.2016-02-041880
K140306CORMATRIX PROTECT ECM ENVELOPECormatrix Cardiovascular, Inc.2014-08-151890
K140789CORMATRIX ECM FOR VASCULAR REPAIRCormatrix Cardiovascular, Inc.2014-07-151060
K111187PATCH, PLEDGET AND INTRACARDIACCormatrix Cardiovascular, Inc.2011-07-26900
K063349CORMATRIX PATCH FOR CARDIAC TISSUE REPAIRCormatrix Cardiovascular, Inc.2007-02-161020
K051405REGENSIS PERICARDIAL PATCHCormatrix Cardiovascular, Inc.2005-08-31920

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