510(k) · Cleared
ClearedIntegra Meshed Bilayer Wound Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Dec 4, 2008 as substantially equivalent to K021792 (Integra Lifesciences Corp., 2002) after a 176-day review. Its family tree reaches back 4 generations to 1988. 10 later devices descend from it.
- Decided
- Dec 4, 2008
- Review
- 176 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K881854 (1988). 12 ancestors in all. 10 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 3 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 2 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 1 generation backK021792 Bilayer Matrix Wound DressingIntegra Lifesciences Corp. · 2002 · Recalled
- This deviceK081635 Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp. · 2008
- Descendant · cites it directly · 4 of its ownK123961 Sentrex Biosponge MPDBionova Medical, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK210949 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK231937 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK240298 Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK210135 PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix…3M Healthcare Business Group · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K123961Sentrex Biosponge MPDBionova Medical, Inc. · 2013 · cites it directly4descendants
- K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022 · 2 generations on3descendants
- K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023 · 3 generations on2descendants
- K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024 · 4 generations on1descendant
- K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing3M Healthcare Business Group · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −3 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −2 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −1 | K021792 | Bilayer Matrix Wound Dressing | Integra Lifesciences Corp. | 2002 | 1 |
| 0 (this device) | K081635 | Integra Meshed Bilayer Wound Matrix | Integra Lifesciences Corp. | 2008 | — |
| +1 | K123961 | Sentrex Biosponge MPD | Bionova Medical, Inc. | 2013 | — |
| +2 | K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2022 | — |
| +3 | K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2023 | — |
| +4 | K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | 2024 | — |
| +1 | K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing | 3M Healthcare Business Group | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K021792 | Bilayer Matrix Wound DressingSummary page 4…ly equivalent in function and intended use to INTEGRATM Bilayer Matrix Wound Dressing, which has been cleared to market under Premarket Notification 510(k) K021792. Device Description: INTEGRATM Meshed Bilayer Wound Matrix is an advanced wound care device comprised of a porous… | 2002 |
What descends from it? (10)
5 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 20 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K123961 (Bionova Medical, Inc., 2013) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K021792.
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. 2008, 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?
INTEGRA™ Meshed Bilayer Wound Matrix is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. The device may be used in conjunction with negative pressure wound therapy. 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/K081635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081635: Integra Meshed Bilayer Wound Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081635
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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