510(k) · Cleared
ClearedMeso Wound Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kensey Nash Corporation · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Feb 10, 2012 as substantially equivalent to K061711 (Cook Biotech, Inc., 2006) after a 133-day review. Its family tree reaches back 1 generation to 2006. 4 later devices descend from it.
- Decided
- Feb 10, 2012
- Review
- 133 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061711 (2006). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK061711 Oasis Wound MatrixCook Biotech, Inc. · 2006
- This deviceK112888 Meso Wound MatrixKensey Nash Corporation · 2012
- Descendant · cites it directly · 2 of its ownK231937 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK240298 Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK243181 Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK141738 Medeor Matrix Wound DressingKensey Nash Corporation Dba Dsm Biomedical · 2015
Most influential descendants
Showing 4 of 4 · See all- K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023 · cites it directly2descendants
- K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024 · 2 generations on1descendant
- K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024 · 2 generations on0descendants
- K141738Medeor Matrix Wound DressingKensey Nash Corporation Dba Dsm Biomedical · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061711 | Oasis Wound Matrix | Cook Biotech, Inc. | 2006 | — |
| 0 (this device) | K112888 | Meso Wound Matrix | Kensey Nash Corporation | 2012 | — |
| +1 | K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2023 | — |
| +2 | K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | 2024 | — |
| +2 | K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | Bionova Medical, Inc. | 2024 | — |
| +1 | K141738 | Medeor Matrix Wound Dressing | Kensey Nash Corporation Dba Dsm Biomedical | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 KGN? 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 KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 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 |
|---|---|---|---|
| * | K061711 | Oasis Wound MatrixSummary page 2…rer Device 510(k) Cook Biotech, Inc. Oasis Wound Matrix K06171 1 Technological Characteristics: Meso Wound Matrix is technologically identical to the cleared KN ECM Surgical Patch (K09406 1).… | 2006 |
| † | K094061 | Kensey Nash Ecm Surgical Patch | 2010 |
What descends from it? (4)
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?
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, 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 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
Meso Wound Matrix is a resorbable porcine mesothelium derived product intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mob's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears), and draining wounds.
The device is intended for one time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112888: Meso Wound Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112888
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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