510(k) Report

510(k) · Decided

Decided

Cardio-Wrap

K090637510(k) TraditionalDecided Jan 7, 2010303-day reviewClass II21 CFR 870.3470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mast Biosurgery USA, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on Jan 7, 2010 as substantially equivalent to K031785 (Macropore Biosurgery, Inc., 2003) and 5 other predicates after a 303-day review. Its family tree reaches back 5 generations to 1992.

Decided
Jan 7, 2010
Review
303 days
Class
Class II
Product code
DXZ
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K921895 (1992). 25 ancestors in all, the oldest K811841 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2003: 3 other ancestors1998: 2 other ancestors1996: 1 other ancestor2001: 3 other ancestors1999: 2 other ancestors1994: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1983: 1 other ancestor1981: 1 other ancestorK921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K980431 · Surgisis · Cook Biotech, Inc. · 1998K020455 · Tissuemend Soft Tissue Repair Matrix · Tei Biosciences, Inc. · 2002K051405 · Regensis Pericardial Patch · Cormatrix Cardiovascular, Inc. · 20051980198519901995200020052010
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 8 other ancestors3 generations back: 7 other ancestors K051405 · Regensis Pericardial Patch · Cormatrix Cardiovascular, Inc. · 2005K020455 · Tissuemend Soft Tissue Repair Matrix · Tei Biosciences, Inc. · 2002K980431 · Surgisis · Cook Biotech, Inc. · 1998K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992−50
  1. Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
  4. 2 generations backK020455 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2002
  5. 1 generation backK051405 Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 2005
  6. This deviceK090637 Cardio-WrapMast Biosurgery USA, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−4K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−3K980431SurgisisCook Biotech, Inc.1998—
−2K020455Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2002—
−1K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.2005—
0 (this device)K090637Cardio-WrapMast Biosurgery USA, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198310
199110
199210
199410
199510
199610
199710
199820
199920
200010
200130
200330
200610
FIG. 1 — Lineage of K090637, 1992–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DXZ device

  1. #1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K031785Macropore Cardio-Wrap (TS)
Summary page 3
…surgical procedures. Design and Materials The design of MAST Biosurgery Cardio-Wrap Bioresorbable Sheet and the predicate devices MacroPore Biosurgery Cardio-Wrap (K03 1785), CorMatrix Cardiovascular CorMatrix Pericardial Patch (1(051405), Bio-Vascular Supple Peni-Guard (1(983602), W. L. Gore Preclud…
Macropore Biosurgery, Inc.2003—
*K051405Regensis Pericardial Patch
Summary page 3
…and MacroPore Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (1(031955), Class II medical devices that were cleared for marketing in the United States under K(03 1785, KO051405,1(983602,1(960532, K061727, 1(03 1955, and respectively. Indications For Use The MAST Biosurgery Cardio-Wrap Bioresorbable Shee…
Cormatrix Cardiovascular, Inc.2005—
*K983602CV Peri-Guard and Vascu-Guard
Summary page 3
…o pre-amendment devices: MacroPore Biosurgery Cardio-Wrap (K(031785), CorMatrix Cardiovascular CorMatrix Pericardial Patch (KO5 1405), Bio-Vascular Supple Peni- Guard (K(983602), W. L. Gore Preclude IMA Sleeve (K960532), W. L. Gore Preclude Vessel Guard K(061727), and MacroPore Biosurgery Surgi-Wrap MAST…
Bio-Vascular, Inc.19983
*K960532Preclude Ima Sleeve
Summary page 3
…gery Cardio-Wrap (K(031785), CorMatrix Cardiovascular CorMatrix Pericardial Patch (KO5 1405), Bio-Vascular Supple Peni- Guard (K(983602), W. L. Gore Preclude IMA Sleeve (K960532), W. L. Gore Preclude Vessel Guard K(061727), and MacroPore Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (1(031955), Class II m…
W. L. Gore & Associates, Inc.1996—
*K061727Gore Preclude Vessel Guard
Summary page 3
…urgi-Wrap MAST Bioresorbable Sheet (1(031955), Class II medical devices that were cleared for marketing in the United States under K(03 1785, KO051405,1(983602,1(960532, K061727, 1(03 1955, and respectively. Indications For Use The MAST Biosurgery Cardio-Wrap Bioresorbable Sheet shares identical indicati…
W. L. Gore & Associates, Inc.2006—
*K031955Macropore Surgi-Wrap Mast Bioresorbable Sheet
Summary page 3
…- Guard (K(983602), W. L. Gore Preclude IMA Sleeve (K960532), W. L. Gore Preclude Vessel Guard K(061727), and MacroPore Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (1(031955), Class II medical devices that were cleared for marketing in the United States under K(03 1785, KO051405,1(983602,1(960532, K061…
Macropore Biosurgery, Inc.2003—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
  • 1 of the 25 ancestors has a recall of any class.

How does its category compare?

All DXZ devices

DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DXZ

1in 2025

2007: 12008: 22009: 12010: 32011: 22012: 12013: 12014: 32015: 22016: 22017: 12020: 12025: 1
2007high 3 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXZ

106in 2014

2010: 91 days median2014: 106 days median
2007high 106 (2014) · low 91 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXZ

2in 2025

2010: 22011: 22013: 22018: 12020: 12023: 22025: 2, 2 Class I2026 (partial year): 1
2007high 2 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DXZ

119in 2025

2007: 502008: 62009: 1092010: 812011: 472012: 212013: 692014: 932015: 1712016: 662017: 302018: 442019: 552020: 1212021: 802022: 772023: 402024: 492025: 119
2007high 171 (2015) · low 6 (2008)2025

MAUDE reports naming product code DXZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—050
20082—06
20091—0109
2010391281
20112—247
20121—021
20131—269
20143106093
20152—0171
20162—066
20171—030
20180—144
20190—055
20201—1121
20210—080
20220—077
20230—240
20240—049
20251—2 (2)119
20260—1—

What is it indicated for?

The Cardio-Wrap Bioresorbable Sheet is intended for reconstruction and repair of defects of the pericardium

Indications for use as stated in the FDA summary.

More from Mast Biosurgery USA, Inc.

4 FDA decisions under this applicant name. See the company

  • K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
  • K061473Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 20061 recall
  • K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005

Recent decisions in DXZ

The DXZ category page

  • K240775PeriBeam® Pericardial MembraneTamabio · 2025
  • K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd. · 2020
  • K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2017
  • K162579VascuCelAdmedus Regen Pty, Ltd. · 2016
  • K152127CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016

https://510kreport.com/device/K090637 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090637: Cardio-Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090637

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026