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 Corporation · FTM Mesh, Surgical
Cleared on May 9, 2006 as substantially equivalent to K043259 (Kensey Nash Corp., 2005) and 1 other predicate after a 25-day review. Its family tree reaches back 7 generations to 1992. 4 later devices descend from it.
- Decided
- May 9, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921895 (1992). 29 ancestors in all, the oldest K830889 (1983). 4 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 backK043259 Bioblanket Surgical MeshKensey Nash Corp. · 2005
- This deviceK061030 Bioblanket Surgical MeshKensey Nash Corporation · 2006
- Descendant · cites it directly · 3 of its ownK091499 Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp. · 2009
- Descendant · 2 generations on · 2 of its ownK103787 Medeor MatrixKensey Nash Corp. · 2011
- Descendant · 3 generations on · 0 of its ownK251690 Arthrex SpeedFLEX™ ImplantArthrex, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK133169 Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical · 2013
Most influential descendants
Showing 4 of 4 · See all- K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp. · 2009 · cites it directly3descendants
- K103787Medeor MatrixKensey Nash Corp. · 2011 · 2 generations on2descendants
- K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc. · 2025 · 3 generations on0descendants
- K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical · 2013 · 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 | K043259 | Bioblanket Surgical Mesh | Kensey Nash Corp. | 2005 | — |
| 0 (this device) | K061030 | Bioblanket Surgical Mesh | Kensey Nash Corporation | 2006 | — |
| +1 | K091499 | Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry) | Kensey Nash Corp. | 2009 | — |
| +2 | K103787 | Medeor Matrix | Kensey Nash Corp. | 2011 | — |
| +3 | K251690 | Arthrex SpeedFLEX™ Implant | Arthrex, Inc. | 2025 | — |
| +3 | K133169 | Meso Tendon Matrix | Kensey Nash Corporation Dba Dsm Biomedical | 2013 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K043259 | Bioblanket Surgical MeshSummary page 1…valent in terms of intended use, technological characteristics, performance and material. Manufacturer Device S10(k) ProCode Kensey Nash Corp. BioBlanket™ Surgical Mesh K043259 FTM Kensey Nash Corp. BioBlanket™ Surgical Mesh K041923 FTM Performance Data: BioBlanket™ Surgical Mesh has been subjected to bi… | 2005 |
| * | K041923 | BioblanketSummary page 1…istics, performance and material. Manufacturer Device S10(k) ProCode Kensey Nash Corp. BioBlanket™ Surgical Mesh K043259 FTM Kensey Nash Corp. BioBlanket™ Surgical Mesh K041923 FTM Performance Data: BioBlanket™ Surgical Mesh has been subjected to biocompatibility, integrity, in-vitro and in-vivo performa… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091499 | Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry) | 2009 | 3 |
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 14 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K091499 (Kensey Nash Corp., 2009) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K043259.
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/K061030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061030: Bioblanket 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/K061030
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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