Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DXZ — Predicate Candidate Screening
90 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
307 days90th percentile
90clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240775 | PeriBeam® Pericardial Membrane | Tamabio | 2025-04-18 | 393 | 0 |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thi | Vascutek, Ltd. | 2020-07-08 | 90 | 0 |
| K162506 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2017-03-09 | 182 | 0 |
| K162579 | VascuCel | Admedus Regen Pty, Ltd. | 2016-10-14 | 29 | 0 |
| K152127 | CorMatrix Tyke | Cormatrix Cardiovascular, Inc. | 2016-02-04 | 188 | 0 |
| K151865 | PremiPatch PTFE Pledget | Aesculap, Inc. | 2015-10-27 | 111 | 0 |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | 2015-01-07 | 127 | 0 |
| K142461 | VASCU-GUARD Peripheral Vascular Patch | Synovis Life Technologies, Inc. | 2014-11-25 | 84 | 1 |
| K140789 | CORMATRIX ECM FOR VASCULAR REPAIR | Cormatrix Cardiovascular, Inc. | 2014-07-15 | 106 | 0 |
| K130872 | CARDIOCEL | Celxcel Pty, Ltd. | 2014-01-30 | 307 | 0 |
| K122306 | SYNOVIS COLLAGEN MATRIX (TBD) | Synovis Surgical Innovations | 2013-03-08 | 219 | 0 |
| K122105 | SMI CARDIOVASCULAR PATCH | Solinas Medical, Inc. | 2012-12-07 | 143 | 0 |
| K112683 | SMI CARDIOVASCULAR PACH | Solimas Medical, Inc. | 2011-12-14 | 90 | 0 |
| K111187 | PATCH, PLEDGET AND INTRACARDIAC | Cormatrix Cardiovascular, Inc. | 2011-07-26 | 90 | 0 |
| K101740 | ALBOSURE POLYESTER VASCULAR PATCH | LeMaitre Vascular, Inc. | 2010-09-20 | 91 | 0 |
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | Cryolife, Inc. | 2010-07-23 | 21 | 2 |
| K090637 | CARDIO-WRAP | Mast Biosurgery USA, Inc. | 2010-01-07 | 303 | 0 |
| K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH | Cryolife, Inc. | 2009-08-07 | 65 | 1 |
| K082139 | EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 | Edwards Lifesciences, LLC | 2008-10-23 | 86 | 0 |
| K081438 | MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT | Lifenet Health | 2008-10-17 | 148 | 0 |
| K063349 | CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR | Cormatrix Cardiovascular, Inc. | 2007-02-16 | 102 | 0 |
| K060396 | IVENA VASCULAR PATCH | Atrium Medical Corp. | 2006-05-12 | 86 | 0 |
| K052416 | PERIPRO PATCH | Hancock/Jaffe Laboratories | 2005-10-25 | 53 | 0 |
| K051405 | REGENSIS PERICARDIAL PATCH | Cormatrix Cardiovascular, Inc. | 2005-08-31 | 92 | 0 |
| K041736 | PFA PATCH | Peritec Biosciences, LLC | 2005-01-13 | 199 | 0 |
| K041716 | PTFE FELTS AND PLEDGETS | Boston Scientific Corp | 2004-07-22 | 28 | 0 |
| K040415 | PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CON | Synovis Surgical Innovations | 2004-04-14 | 56 | 1 |
| K040162 | CORRESTORE PATCH SYSTEM | Somanetics Corp. | 2004-03-16 | 50 | 0 |
| K031948 | PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 | Pm Devices, Inc. | 2003-09-16 | 84 | 0 |
| K031586 | CORRESTORE PATCH SYSTEM | Somanetics Corp. | 2003-08-07 | 78 | 0 |
| K022093 | CHASE CARDIOVASCULAR PATCH KIT | Chase Medical, Inc. | 2002-09-20 | 85 | 0 |
| K021129 | CHARE CARIOVASCULAR PATCH | Chase Medical, Inc. | 2002-06-03 | 56 | 0 |
| K020233 | CHASE CARDIOVASCULAR PATCH KIT | Chase Medical, Inc. | 2002-03-14 | 50 | 0 |
| K020132 | CHASE CARDIOVASCULAR PATCH KIT | Chase Medical, Inc. | 2002-02-26 | 42 | 0 |
| K011487 | CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, | Somanetics Corp. | 2001-11-21 | 190 | 0 |
| K012098 | PRECLUDE PERICARDIAL MEMBRANE | W. L. Gore & Associates, Inc. | 2001-09-20 | 77 | 0 |
| K012248 | CHASE CARDIOVASCULAR PATCH | Chase Medical, Inc. | 2001-08-10 | 24 | 0 |
| K003467 | CHASE CARDIOVASCULAR PATCH | Chase Medical, Inc. | 2001-01-29 | 82 | 0 |
| K001785 | SURGISIS PERIPHERAL VASCULAR PATCH | Cook Biotech, Inc. | 2000-12-27 | 197 | 1 |
| K003070 | ETHIBOND EXCEL VALVE LOOP SUTURE | ETHICON, Inc. | 2000-11-07 | 36 | 0 |
| K001662 | CHASE CARDIOVASCULAR PATCH | Chase Medical, Inc. | 2000-08-02 | 63 | 0 |
| K994032 | FLUORO-TEX CARDIOVASCULAR PATCH | Bridger Biomed, Inc. | 2000-07-07 | 224 | 0 |
| K993288 | SULZER CARBOMEDICS CARDIOFIX PERICARDIUM | Sulzer Carbomedics, Inc. | 1999-12-29 | 89 | 0 |
| K992776 | UNI-GRAFT K DV PATCH | Atrium Medical Corp. | 1999-11-16 | 90 | 0 |
| K984526 | ACUSEAL CARDIOVASCULAR PATCH | W. L. Gore & Associates, Inc. | 1999-04-08 | 108 | 0 |
| K983602 | CV PERI-GUARD AND VASCU-GUARD | Bio-Vascular, Inc. | 1998-11-12 | 30 | 3 |
| K982810 | SHELHIGH NO-REACT VASCUPATCH | Shelhigh, Inc. | 1998-10-28 | 78 | 0 |
| K974914 | SHELHIGH NO-REACT PERICARDIAL PATCHES | Shelhigh, Inc. | 1998-06-03 | 177 | 0 |
| K972201 | PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE | Sulzer Carbomedics, Inc. | 1998-04-14 | 307 | 0 |
| K971726 | CV PERI-GUARD - CARDIOVASCULAR PATCH | Bio-Vascular, Inc. | 1998-04-10 | 336 | 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