510(k) · Cleared
ClearedCook ECM Powder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech Incorporated · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Aug 19, 2015 as substantially equivalent to K061711 (Cook Biotech, Inc., 2006) after a 28-day review. Its family tree reaches back 1 generation to 2006. 7 later devices descend from it.
- Decided
- Aug 19, 2015
- Review
- 28 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061711 (2006). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK061711 Oasis Wound MatrixCook Biotech, Inc. · 2006
- This deviceK152033 Cook ECM PowderCook Biotech Incorporated · 2015
- Descendant · cites it directly · 3 of its ownK172399 MicroMatrixAcell, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK230980 MicroMatrix® FlexAcell, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK172593 XCelliStem Wound PowderStemsys · 2018
- Descendant · 3 generations on · 0 of its ownK253521 Ecmt-100 WMDEcm Therapeutics, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241706 MicroMatrix® UBM ParticulateAcell, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K172399MicroMatrixAcell, Inc. · 2017 · cites it directly3descendants
- K230980MicroMatrix® FlexAcell, Inc. · 2023 · 2 generations on1descendant
- K172593XCelliStem Wound PowderStemsys · 2018 · cites it directly1descendant
- K253521Ecmt-100 WMDEcm Therapeutics, Inc. · 2026 · 3 generations on0descendants
- K241706MicroMatrix® UBM ParticulateAcell, Inc. · 2024 · 2 generations on0descendants
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) | K152033 | Cook ECM Powder | Cook Biotech Incorporated | 2015 | — |
| +1 | K172399 | MicroMatrix | Acell, Inc. | 2017 | — |
| +2 | K230980 | MicroMatrix® Flex | Acell, Inc. | 2023 | — |
| +1 | K172593 | XCelliStem Wound Powder | Stemsys | 2018 | — |
| +3 | K253521 | Ecmt-100 WMD | Ecm Therapeutics, Inc. | 2026 | — |
| +2 | K241706 | MicroMatrix® UBM Particulate | Acell, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K061711 | Oasis Wound MatrixSummary page 4…metic act apply to this device. Predicate Device: The predicate device for Cook® ECM Powder is Oasis® Wound Matrix manufactured by Cook Biotech Incorporated (510(k) No. K061711) cleared on July 19, 2006. Reference Device: The reference device for this submission is ACell™ Powdered Wound Dressing (510(k)… | 2006 |
| † | K060888 | Acell Powder Wound Dressing | 2006 |
What descends from it? (7)
3 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. 2015, 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?
Indications For Use: Cook® ECM Powder 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 provided sterile and intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152033 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152033: Cook ECM Powder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152033
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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