510(k) · Cleared
ClearedBioblanket
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 Sep 8, 2004 as substantially equivalent to K011025 (Organogenesis, Inc., 2001) after a 54-day review. Its family tree reaches back 1 generation to 2001. 11 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 54 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011025 (2001). 11 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK011025 Fortaflex Surgical MeshOrganogenesis, Inc. · 2001
- This deviceK041923 BioblanketKensey Nash Corp. · 2004
- Descendant · cites it directly · 10 of its ownK043259 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
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K043259Bioblanket Surgical MeshKensey Nash Corp. · 2005 · cites it directly10descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011025 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2001 | — |
| 0 (this device) | K041923 | Bioblanket | Kensey Nash Corp. | 2004 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K011025 | Fortaflex Surgical MeshSummary page 1…cal mesh devices previously cleared for commercial distribution. The relevant predicate device is Organogenesis' Forta~lex~', which was cleared by FDA under 510Ok number K0 11025. Statement of Substantial Equivalence: BioBlanket~m is substantially equivalent to the predicate device, having similar intende… | 2001 |
What descends from it? (11)
See all 113 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?
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 reinforcement of soft tissue where weakness exists and for the repair of ruptured or damaged soft tissues. The device is intended for one time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041923: Bioblanket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041923
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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