510(k) · Cleared
ClearedMeso Bilayer Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kensey Nash Corporation Dba Dsm Biomedical · FTM Mesh, Surgical
Cleared on Oct 30, 2013 as substantially equivalent to K094061 (Kensey Nash Corporation, 2010) after a 121-day review. Its family tree reaches back 7 generations to 1992. 6 later devices descend from it.
- Decided
- Oct 30, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921895 (1992). 35 ancestors in all, the oldest K830889 (1983). 6 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 4 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 3 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 2 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 1 generation backK094061 Kensey Nash Ecm Surgical PatchKensey Nash Corporation · 2010
- This deviceK132025 Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013
- Descendant · cites it directly · 5 of its ownK163217 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK232602 3DMatrix Surgical MeshPrintbio, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK173333 GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK243302 3DMatrix DynaFlex (DynaFlex)Printbio, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK222919 GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017 · cites it directly5descendants
- K2326023DMatrix Surgical MeshPrintbio, Inc. · 2024 · 2 generations on1descendant
- K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018 · 2 generations on1descendant
- K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc. · 2025 · 3 generations on0descendants
- K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −6 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −4 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −3 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −1 | K094061 | Kensey Nash Ecm Surgical Patch | Kensey Nash Corporation | 2010 | — |
| 0 (this device) | K132025 | Meso Bilayer Surgical Mesh | Kensey Nash Corporation Dba Dsm Biomedical | 2013 | — |
| +1 | K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017 | — |
| +2 | K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | 2024 | — |
| +2 | K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | 2018 | — |
| +3 | K243302 | 3DMatrix DynaFlex (DynaFlex) | Printbio, Inc. | 2025 | — |
| +3 | K222919 | GORE® ENFORM Biomaterial | W. L. Gore and Associates, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 FTM? 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 FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K094061 | Kensey Nash Ecm Surgical PatchSummary page 2…use, product design, material, and function of Mesa Bilayer Surgical Mesh is substantially equivalent to the FDA cleared predicate device Kensey Nash ECM Surgical Patch (K094061). Characteristic Meso Bilayer Surgical Mesh Kensey Nash ECM Surgical Patch Mesa Bilayer Surgical… | 2010 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163217 | GORE BIO-A Tissue Reinforcement | 2017 | 5 |
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 21 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 35 ancestors has a recall of any class.
- Of its descendants, K163217 (W. L. Gore & Associates, Inc., 2017) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K094061.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Mesa Bilayer Surgical Mesh is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g. hiatal, femoral, paracolostomy, umbilical.)
Mesa Bilayer Surgical Mesh is supplied sterile and for one time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132025: Meso Bilayer Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132025
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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