510(k) · Cleared
ClearedOasis Wound Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jul 19, 2006 after a 30-day review. The FDA summary names no predicate by number. 79 later devices descend from it.
- Decided
- Jul 19, 2006
- Review
- 30 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 0
79 later devices descend from it, 16 citing it directly.
- This deviceK061711 Oasis Wound MatrixCook Biotech, Inc. · 2006
- Descendant · cites it directly · 20 of its ownK083440 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
- Descendant · cites it directly · 19 of its ownK092096 Endoform Dermal TemplateMesynthes, Ltd. · 2010 · Recalled
- Descendant · cites it directly · 9 of its ownK140510 Miromatrix Wound MatrixMiromatrix Medical, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK152033 Cook ECM PowderCook Biotech Incorporated · 2015
- Descendant · 2 generations on · 6 of its ownK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · Recalled
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K083440Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008 · cites it directly20descendants
- K092096Endoform Dermal TemplateMesynthes, Ltd. · 2010 · cites it directly19descendants
- K140510Miromatrix Wound MatrixMiromatrix Medical, Inc. · 2014 · cites it directly9descendants
- K152033Cook ECM PowderCook Biotech Incorporated · 2015 · cites it directly7descendants
- K100261Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061711 | Oasis Wound Matrix | Cook Biotech, Inc. | 2006 | — |
| +1 | K083440 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2008 | — |
| +1 | K092096 | Endoform Dermal Template | Mesynthes, Ltd. | 2010 | 3 |
| +1 | K140510 | Miromatrix Wound Matrix | Miromatrix Medical, Inc. | 2014 | — |
| +1 | K152033 | Cook ECM Powder | Cook Biotech Incorporated | 2015 | — |
| +2 | K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold | Tei Biosciences, Inc. | 2010 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 10 | 0 |
| 2025 | 5 | 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?
The FDA summary names no predicate by number.
What descends from it? (79)
See all 7916 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083440 | Primatrix Dermal Repair Scaffold | 2008 | 20 |
| K092096 | Endoform Dermal Template | 2010 | 19 |
| K140510 | Miromatrix Wound Matrix | 2014 | 9 |
| K152033 | Cook ECM Powder | 2015 | 7 |
| K132343 | Marigen Wound Dressing | 2013 | 5 |
| K112888 | Meso Wound Matrix | 2012 | 4 |
| K193552 | InnovaMatrix | 2020 | 3 |
| K080949 | Keratec Wound Dressings | 2009 | 3 |
| K073251 | Hyalomatrix PA | 2007 | 2 |
| K181330 | NeoMatriX Wound Matrix | 2018 | 1 |
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?
- Of its descendants, K083440 (Tei Biosciences, Inc., 2008) has gone furthest, with 20 descendants of its own.
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?
The Oasis Wound Matrix is intended for the management of 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-Moh's
surgery, post-laser surgery, podiatric, wound
dehiscence);
- Trauma wounds (abrasions, lacerations,
second-degree burns, and skin tears);
- Draining wounds.
The device is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061711: Oasis 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/K061711
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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