510(k) · Cleared
ClearedKensey Nash Ecm Surgical Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kensey Nash Corporation · FTM Mesh, Surgical
Cleared on May 18, 2010 as substantially equivalent to K992159 (Cook Biotech, Inc., 1999) and 4 other predicates after a 138-day review. Its family tree reaches back 6 generations to 1992. 10 later devices descend from it.
- Decided
- May 18, 2010
- Review
- 138 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K921895 (1992). 34 ancestors in all, the oldest K830889 (1983). 10 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 3 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 2 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 1 generation backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- This deviceK094061 Kensey Nash Ecm Surgical PatchKensey Nash Corporation · 2010
- Descendant · cites it directly · 6 of its ownK132025 Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013
- Descendant · 2 generations on · 5 of its ownK163217 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK103787 Medeor MatrixKensey Nash Corp. · 2011
- Descendant · 3 generations on · 1 of its ownK232602 3DMatrix Surgical MeshPrintbio, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK173333 GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013 · cites it directly6descendants
- K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017 · 2 generations on5descendants
- K103787Medeor MatrixKensey Nash Corp. · 2011 · cites it directly2descendants
- K2326023DMatrix Surgical MeshPrintbio, Inc. · 2024 · 3 generations on1descendant
- K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −5 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −3 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −2 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| 0 (this device) | K094061 | Kensey Nash Ecm Surgical Patch | Kensey Nash Corporation | 2010 | — |
| +1 | K132025 | Meso Bilayer Surgical Mesh | Kensey Nash Corporation Dba Dsm Biomedical | 2013 | — |
| +2 | K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017 | — |
| +1 | K103787 | Medeor Matrix | Kensey Nash Corp. | 2011 | — |
| +3 | K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | 2024 | — |
| +3 | K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | 2018 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K992159 | Surgisis SlingSummary page 1…ile in double-layer packages. The product is packaged dry (lyophilized) to be hydrated prior to use. Predicate Devices: Manufacturer Device 510(k)# Cook, Inc. SurgiSis K992159 Cook, Inc. SurgiSiS K034039 Cook, Inc. SurgiSiS K062697 Organogenesis Inc. FortaFlex K011025 Organogenesis Inc. FortaFlex K020049… | 1999 |
| * | K034039 | Sis Plastic Surgery MatrixSummary page 1…. The product is packaged dry (lyophilized) to be hydrated prior to use. Predicate Devices: Manufacturer Device 510(k)# Cook, Inc. SurgiSis K992159 Cook, Inc. SurgiSiS K034039 Cook, Inc. SurgiSiS K062697 Organogenesis Inc. FortaFlex K011025 Organogenesis Inc. FortaFlex K020049 Intended Use: The Kensey… | 2004 |
| * | K062697 | Sis Hernia Repair Device, Surgisis Gold Hernia Repair GraftSummary page 1…y (lyophilized) to be hydrated prior to use. Predicate Devices: Manufacturer Device 510(k)# Cook, Inc. SurgiSis K992159 Cook, Inc. SurgiSiS K034039 Cook, Inc. SurgiSiS K062697 Organogenesis Inc. FortaFlex K011025 Organogenesis Inc. FortaFlex K020049 Intended Use: The Kensey Nash ECM Surgical Patch is i… | 2006 |
| * | K011025 | Fortaflex Surgical MeshSummary page 1…to use. Predicate Devices: Manufacturer Device 510(k)# Cook, Inc. SurgiSis K992159 Cook, Inc. SurgiSiS K034039 Cook, Inc. SurgiSiS K062697 Organogenesis Inc. FortaFlex K011025 Organogenesis Inc. FortaFlex K020049 Intended Use: The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce… | 2001 |
| * | K020049 | Fortaflex Surgical MeshSummary page 1…urer Device 510(k)# Cook, Inc. SurgiSis K992159 Cook, Inc. SurgiSiS K034039 Cook, Inc. SurgiSiS K062697 Organogenesis Inc. FortaFlex K011025 Organogenesis Inc. FortaFlex K020049 Intended Use: The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce soft tissues where weakness exists i… | 2002 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2.0 years on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K132025 (Kensey Nash Corporation Dba Dsm Biomedical, 2013) has gone furthest, with 6 descendants of its own.
- 12 other devices also cite its predicate K992159.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair, reinforcement in plastic and reconstructive surgery, and in the urological, gynecological (excluding transvaginal repair of pelvic organ prolapse), and gastroenterological anatomy including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement…
Read the full statement (131 words)
The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair, reinforcement in plastic and reconstructive surgery, and in the urological, gynecological (excluding transvaginal repair of pelvic organ prolapse), and gastroenterological anatomy 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), urethral and vaginal prolapse repair (excluding transvaginal repair of pelvic organ prolapse), colon prolapse repair, rectal prolapse repair (excluding rectocele) using an abdominal approach, reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), bladder support, and sacrocolposuspension.
The Kensey Nash ECM Surgical Patch is supplied sterile and intended for one time use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K094061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K094061: Kensey Nash Ecm Surgical Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094061
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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