510(k) · Cleared
ClearedMacropore Cardio-Wrap (TS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macropore Biosurgery, Inc. · OMH Pericardial Patch To Facilitate Revision Surgeries
Cleared on Sep 4, 2003 as substantially equivalent to K983602 (Bio-Vascular, Inc., 1998) and 2 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.
- Decided
- Sep 4, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- OMH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K921895 (1992). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 2 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 1 generation backK983602 CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 1998 · Recalled
- This deviceK031785 Macropore Cardio-Wrap (TS)Macropore Biosurgery, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK090637 Cardio-WrapMast Biosurgery USA, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K090637Cardio-WrapMast Biosurgery USA, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −2 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −1 | K983602 | CV Peri-Guard and Vascu-Guard | Bio-Vascular, Inc. | 1998 | 3 |
| 0 (this device) | K031785 | Macropore Cardio-Wrap (TS) | Macropore Biosurgery, Inc. | 2003 | — |
| +1 | K090637 | Cardio-Wrap | Mast Biosurgery USA, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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 OMH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983602 | CV Peri-Guard and Vascu-GuardSummary page 3…ri-Guard, Sulzer Carbomedics Cardio Fix, and W.L. Gore Preclude Pericardial Membrane; Class 11 medical devices that were cleared for marketing in the United States under K983602, K993288, and KO12098, respectively. Indications For Use The MacroPore Cardio- Wrap (TS) shares identical indications for use p… | 1998 |
| * | K993288 | Sulzer Carbomedics Cardiofix PericardiumSummary page 3…Sulzer Carbomedics Cardio Fix, and W.L. Gore Preclude Pericardial Membrane; Class 11 medical devices that were cleared for marketing in the United States under K983602, K993288, and KO12098, respectively. Indications For Use The MacroPore Cardio- Wrap (TS) shares identical indications for use principles… | 1999 |
| * | K012098 | Preclude Pericardial Membrane | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090637 | Cardio-Wrap | 2010 | 0 |
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 11 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K090637 (Mast Biosurgery USA, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K983602.
How does its category compare?
All OMH devicesOMH Pericardial Patch To Facilitate Revision Surgeries: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMH
FDA has decided no OMH device since 2007.
Median 510(k) review, days · OMH
Too few OMH 510(k)s in any year since 2007 to give a median.
Recalls per year · OMH
No recall names OMH since 2007.
Adverse event reports per year · OMH
No MAUDE report names OMH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MacroPore Cardio-Wrap (TS) is indicated for use as a pericardium replacement device in patients that may require re-operation within six months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031785: Macropore Cardio-Wrap (TS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031785
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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