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

Cardica, Inc. — Predicate Candidate Screening

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

40 daysmedian FDA review time
332 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/Cardica, Inc.2016-07-20890
K151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cardica, Inc.2016-01-152680
K140118MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE Cardica, Inc.2014-02-25402
K140170MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITECardica, Inc.2014-02-19272
K132581MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE Cardica, Inc.2014-01-071441
K101018CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-0Cardica, Inc.2010-06-25731
K091017CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-00000Cardica, Inc.2009-04-29200
K090872MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEMCardica, Inc.2009-04-21221
K081225CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEMCardica, Inc.2008-09-051280
K073304CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XACardica, Inc.2007-12-20270
K073123CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-00Cardica, Inc.2007-12-06301
K070548C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEMCardica, Inc.2007-03-29311
K063644CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEMCardica, Inc.2007-01-11351
K053524C-PORT DISTAL ANASTOMOSIS SYSTEMCardica, Inc.2006-11-163321
K040832C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORCardica, Inc.2005-11-105890

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