510(k) · Cleared
Recalled · Class II · 2019E-Z Derm Biosynthetic Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brennen Medical, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jul 11, 1994 after a 258-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled once.
- Decided
- Jul 11, 1994
- Review
- 258 days
- Class
- Class U
- Product code
- KGN
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK935189 E-Z Derm Biosynthetic Wound DressingBrennen Medical, Inc. · 1994
- Descendant · cites it directly · 5 of its ownK020732 SS MatrixCook Biotech, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK061474 Collawound DressingCollamatrix Co., Inc. · 2006
- Descendant · 3 generations on · 2 of its ownK090894 Collawound Wound DressingCollamatrix Co., Inc. · 2009
- Descendant · 4 generations on · 1 of its ownK162348 ABCcolla Collagen MatrixAcro Biomedical Co., Ltd. · 2017
- Descendant · 5 generations on · 0 of its ownK233378 ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K020732SS MatrixCook Biotech, Inc. · 2002 · cites it directly5descendants
- K061474Collawound DressingCollamatrix Co., Inc. · 2006 · 2 generations on3descendants
- K090894Collawound Wound DressingCollamatrix Co., Inc. · 2009 · 3 generations on2descendants
- K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd. · 2017 · 4 generations on1descendant
- K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd. · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935189 | E-Z Derm Biosynthetic Wound Dressing | Brennen Medical, Inc. | 1994 | — |
| +1 | K020732 | SS Matrix | Cook Biotech, Inc. | 2002 | — |
| +2 | K061474 | Collawound Dressing | Collamatrix Co., Inc. | 2006 | — |
| +3 | K090894 | Collawound Wound Dressing | Collamatrix Co., Inc. | 2009 | — |
| +4 | K162348 | ABCcolla Collagen Matrix | Acro Biomedical Co., Ltd. | 2017 | — |
| +5 | K233378 | ABCcolla® Collagen ADM Scaffold | Acro Biomedical Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020732 | SS Matrix | 2002 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2019 | Class II | Z-1243-2019 | Equipment maintenance | Intermittent heat seal failures on the outer pouch of some EZ Derm products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K020732 (Cook Biotech, Inc., 2002) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K935189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935189: E-Z Derm Biosynthetic Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935189
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026