510(k) · Cleared
ClearedMatriDerm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medskin Solutions Dr. Suwelack AG · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jan 7, 2021 as substantially equivalent to K153690 (Tei Biosciences, Inc., 2016) after a 210-day review. Its family tree reaches back 8 generations to 1988. 2 later devices descend from it.
- Decided
- Jan 7, 2021
- Review
- 210 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K881854 (1988). 14 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 7 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 6 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 5 generations backK023778 DressskinTei Biosciences, Inc. · 2003
- 4 generations backK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- 3 generations backK083440 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
- 2 generations backK131286 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2013
- 1 generation backK153690 PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2016 · Recalled
- This deviceK201577 MatriDermMedskin Solutions Dr. Suwelack AG · 2021
- Descendant · cites it directly · 0 of its ownK261224 MatriDermMedskin Solutions Dr. Suwelack AG · 2026
- Descendant · cites it directly · 0 of its ownK250864 MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −7 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −6 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −5 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| −4 | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| −3 | K083440 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2008 | — |
| −2 | K131286 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2013 | — |
| −1 | K153690 | PriMatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2016 | 4 |
| 0 (this device) | K201577 | MatriDerm | Medskin Solutions Dr. Suwelack AG | 2021 | — |
| +1 | K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | 2026 | — |
| +1 | K250864 | MatriDerm pluS+ Bi-Layer | Medskin Solutions Dr. Suwelack AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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.
What descends from it? (2)
2 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?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K261224 (Medskin Solutions Dr. Suwelack AG, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153690.
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. 2021, 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?
MatriDerm is indicated for the management of wounds including:
- Full thickness and partial thickness wounds
- Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers)
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- Partial thickness burns
- Trauma wounds (abrasions, lacerations and skin tears)
- Draining wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201577: MatriDerm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201577
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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