510(k) · Cleared
Recalled · Class III · 2022CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Strukmyer Medical · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jul 25, 2017 as substantially equivalent to K012990 (Biocore Medical Technologies, Inc., 2001) after a 50-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 25, 2017
- Review
- 50 days
- Class
- Class U
- Product code
- KGN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012990 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK012990 Collatek PowderBiocore Medical Technologies, Inc. · 2001
- This deviceK171645 CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen…Strukmyer Medical · 2017
- Descendant · cites it directly · 0 of its ownK260596 Collagen Wound PowderVentris Medical · 2026
- Descendant · cites it directly · 0 of its ownK254034 Roosin Collagen PowderRoosin Medical Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK232796 LUOFUCON® Collagen Particles (Collagen Wound Dressing)Huizhou Foryou Medical Devices Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K260596Collagen Wound PowderVentris Medical · 2026 · cites it directly0descendants
- K254034Roosin Collagen PowderRoosin Medical Co., Ltd. · 2026 · cites it directly0descendants
- K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)Huizhou Foryou Medical Devices Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012990 | Collatek Powder | Biocore Medical Technologies, Inc. | 2001 | — |
| 0 (this device) | K171645 | CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound… | Strukmyer Medical | 2017 | — |
| +1 | K260596 | Collagen Wound Powder | Ventris Medical | 2026 | — |
| +1 | K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | 2026 | — |
| +1 | K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K012990 | Collatek PowderSummary page 4…Dressing, Wound, Collagen Regulatory Class: Unclassified Product Code: KGN III. PREDICATE DEVICE: CollaTek Powder K012990, Biocore Medical Technologies, Inc. (Now sold under the name Medifil II Particles by Human BioSciences, Inc., Gaith… | 2001 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class III | Z-1789-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage… |
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. 2017, 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?
CoMatryx Collagen Wound Dressing may be used in the management of partial and full thickness wounds, pressure
(stage 1-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, 1st and 2nd
degree burns, cuts, abrasions, and surgical wounds.
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/K171645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171645: CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171645
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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