510(k) · Cleared
Recalled · 2009Bilayer Matrix Wound Dressing
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 Aug 14, 2002 as substantially equivalent to K993948 (Cook Biotech, Inc., 2000) and 3 other predicates after a 75-day review. Its family tree reaches back 3 generations to 1988. 53 later devices descend from it. It has been recalled once.
- Decided
- Aug 14, 2002
- Review
- 75 days
- Class
- Class U
- Product code
- KGN
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K881854 (1988). 11 ancestors in all. 53 later devices descend from it, 9 citing it directly.
- Root · 3 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 2 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 1 generation backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- This deviceK021792 Bilayer Matrix Wound DressingIntegra Lifesciences Corp. · 2002
- Descendant · cites it directly · 19 of its ownK092096 Endoform Dermal TemplateMesynthes, Ltd. · 2010 · Recalled
- Descendant · cites it directly · 10 of its ownK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
- Descendant · cites it directly · 10 of its ownK081635 Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp. · 2008
- Descendant · cites it directly · 5 of its ownK142879 BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015
- Descendant · cites it directly · 5 of its ownK132343 Marigen Wound DressingKerecis Limited · 2013
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K092096Endoform Dermal TemplateMesynthes, Ltd. · 2010 · cites it directly19descendants
- K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014 · cites it directly10descendants
- K081635Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp. · 2008 · cites it directly10descendants
- K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015 · cites it directly5descendants
- K132343Marigen Wound DressingKerecis Limited · 2013 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −2 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −1 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| 0 (this device) | K021792 | Bilayer Matrix Wound Dressing | Integra Lifesciences Corp. | 2002 | — |
| +1 | K092096 | Endoform Dermal Template | Mesynthes, Ltd. | 2010 | 3 |
| +1 | K132397 | Gore Bio-a Wound Matrix | W. L. Gore & Associates, Inc. | 2014 | — |
| +1 | K081635 | Integra Meshed Bilayer Wound Matrix | Integra Lifesciences Corp. | 2008 | — |
| +1 | K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015 | — |
| +1 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 8 | 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? (4)
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 |
|---|---|---|---|
| * | K993948 | Sis Wound Dressing IISummary page 3…y equivalent in function and intended use to the following products which have been cleared to market under Premarket Notifications 510(k): Oasis™ SIS Wound Dressing 11 (K993948), Fortaderm™ Wound Dressing (K014129), VitaChoice™ Wound Dressing (K896455) and Biobrane® II Temporary Wound Dressing (K896110).… | 2000 |
| * | K014129 | Promogran Matrix Wound DressingSummary page 3…use to the following products which have been cleared to market under Premarket Notifications 510(k): Oasis™ SIS Wound Dressing 11 (K993948), Fortaderm™ Wound Dressing (K014129), VitaChoice™ Wound Dressing (K896455) and Biobrane® II Temporary Wound Dressing (K896110). Intended Use: Bilayer Matrix Wound D… | 2002 |
| * | K896455 | Vitachoice Wound DressingSummary page 3…ave been cleared to market under Premarket Notifications 510(k): Oasis™ SIS Wound Dressing 11 (K993948), Fortaderm™ Wound Dressing (K014129), VitaChoice™ Wound Dressing (K896455) and Biobrane® II Temporary Wound Dressing (K896110). Intended Use: Bilayer Matrix Wound Dressing is indicated for the managemen… | 1990 |
| * | K896110 | Biobrane (R) IISummary page 3…ions 510(k): Oasis™ SIS Wound Dressing 11 (K993948), Fortaderm™ Wound Dressing (K014129), VitaChoice™ Wound Dressing (K896455) and Biobrane® II Temporary Wound Dressing (K896110). Intended Use: Bilayer Matrix Wound Dressing is indicated for the management of wounds including: partial and full thickness wo… | 1989 |
What descends from it? (53)
See all 539 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092096 | Endoform Dermal Template | 2010 | 19 |
| K132397 | Gore Bio-a Wound Matrix | 2014 | 10 |
| K081635 | Integra Meshed Bilayer Wound Matrix | 2008 | 10 |
| K142879 | BTM Wound Dressing | 2015 | 5 |
| K132343 | Marigen Wound Dressing | 2013 | 5 |
| K090894 | Collawound Wound Dressing | 2009 | 2 |
| K073251 | Hyalomatrix PA | 2007 | 2 |
| K090823 | Theraform Bilayer | 2009 | 0 |
| K081724 | Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan)… | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 10, 2009 | Not classified | Z-1174-2009 | Nonconforming Material/Component | Package Seal Integrity: Integra became aware of the potential of open seals in the foil pouch of the Integra Bilayer Matrix Wound Dressings. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K092096 (Mesynthes, Ltd., 2010) has gone furthest, with 19 descendants of its own.
- 9 other devices also cite its predicate K993948.
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.
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?
Bilayer Matrix Wound Dressing 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 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/K021792 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021792: Bilayer Matrix Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021792
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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