510(k) · Cleared
ClearedBioblanket Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kensey Nash Corp. · FTM Mesh, Surgical
Cleared on Aug 15, 2005 as substantially equivalent to K041923 (Kensey Nash Corp., 2004) and 2 other predicates after a 264-day review. Its family tree reaches back 6 generations to 1992. 10 later devices descend from it.
- Decided
- Aug 15, 2005
- Review
- 264 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K921895 (1992). 28 ancestors in all, the oldest K830889 (1983). 10 later devices descend from it, 3 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 deviceK043259 Bioblanket Surgical MeshKensey Nash Corp. · 2005
- Descendant · cites it directly · 4 of its ownK061030 Bioblanket Surgical MeshKensey Nash Corporation · 2006
- Descendant · 2 generations on · 3 of its ownK091499 Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp. · 2009
- Descendant · 3 generations on · 2 of its ownK103787 Medeor MatrixKensey Nash Corp. · 2011
- Descendant · cites it directly · 2 of its ownK082079 Regen Collagen Scaffold (CS)Regen Biologics, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK170364 Collagen Meniscus Implant XLIvy Sports Medicine, LLC · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K061030Bioblanket Surgical MeshKensey Nash Corporation · 2006 · cites it directly4descendants
- K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp. · 2009 · 2 generations on3descendants
- K103787Medeor MatrixKensey Nash Corp. · 2011 · 3 generations on2descendants
- K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc. · 2008 · cites it directly2descendants
- K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC · 2017 · 2 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) | K043259 | Bioblanket Surgical Mesh | Kensey Nash Corp. | 2005 | — |
| +1 | K061030 | Bioblanket Surgical Mesh | Kensey Nash Corporation | 2006 | — |
| +2 | K091499 | Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry) | Kensey Nash Corp. | 2009 | — |
| +3 | K103787 | Medeor Matrix | Kensey Nash Corp. | 2011 | — |
| +1 | K082079 | Regen Collagen Scaffold (CS) | Regen Biologics, Inc. | 2008 | — |
| +2 | K170364 | Collagen Meniscus Implant XL | Ivy Sports Medicine, LLC | 2017 | — |
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 | 1 | 0 |
| 1998 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K041923 | BioblanketSummary page 1…valent in terms of intended use, technological characteristics, performance and material. Manufacturer Device 510(k) ProCode Kensey Nash Corp. BioBlanket™ Surgical Mesh K041923 FTM Organogenesis, Inc. FortaFlex™ Surgical Mesh K020049 FTM DePuy, Inc. Rmpre" Onthobiologic Soft Tissue Implant ~ K031969 FTM… | 2004 |
| * | K020049 | Fortaflex Surgical MeshSummary page 1…tics, performance and material. Manufacturer Device 510(k) ProCode Kensey Nash Corp. BioBlanket™ Surgical Mesh K041923 FTM Organogenesis, Inc. FortaFlex™ Surgical Mesh K020049 FTM DePuy, Inc. Rmpre" Onthobiologic Soft Tissue Implant ~ K031969 FTM Performance Data: BioBlanket™ Surgical Mesh was subjected… | 2002 |
| * | K031969 | Depuy Restore Orthobiologic Soft Tissue ImplantSummary page 1…Kensey Nash Corp. BioBlanket™ Surgical Mesh K041923 FTM Organogenesis, Inc. FortaFlex™ Surgical Mesh K020049 FTM DePuy, Inc. Rmpre" Onthobiologic Soft Tissue Implant ~ K031969 FTM Performance Data: BioBlanket™ Surgical Mesh was subjected to biocompatibility, integrity, in-vitro and in- vivo performance… | 2003 |
What descends from it? (10)
3 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 13 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K061030 (Kensey Nash Corporation, 2006) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K041923.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
BioBlanket™ Surgical Mesh is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to defects of the thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is 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/K043259 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043259: Bioblanket Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043259
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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