510(k) · Cleared
ClearedCollagen Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dalim Tissen Co., Ltd. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jun 1, 2012 as substantially equivalent to K090812 (Sewon Cellontech Co., Ltd., 2009) after a 269-day review. Its family tree reaches back 6 generations to 1988. 4 later devices descend from it.
- Decided
- Jun 1, 2012
- Review
- 269 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K881854 (1988). 11 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 5 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 4 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 3 generations backK023778 DressskinTei Biosciences, Inc. · 2003
- 2 generations backK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- 1 generation backK090812 Theraform Standard/SheetSewon Cellontech Co., Ltd. · 2009
- This deviceK112580 Collagen Wound DressingDalim Tissen Co., Ltd. · 2012
- Descendant · cites it directly · 2 of its ownK182725 ApisSweetbio, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK222143 Apis (R), Veris (TM)Sweetbio, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK211972 Omeza Collagen MatrixOmeza, LLC · 2021
- Descendant · cites it directly · 0 of its ownK140456 Bio-Connekt Wound MatrixMLM Biologics, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K182725ApisSweetbio, Inc. · 2019 · cites it directly2descendants
- K222143Apis (R), Veris (TM)Sweetbio, Inc. · 2023 · 2 generations on0descendants
- K211972Omeza Collagen MatrixOmeza, LLC · 2021 · 2 generations on0descendants
- K140456Bio-Connekt Wound MatrixMLM Biologics, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −5 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −4 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −3 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| −2 | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| −1 | K090812 | Theraform Standard/Sheet | Sewon Cellontech Co., Ltd. | 2009 | — |
| 0 (this device) | K112580 | Collagen Wound Dressing | Dalim Tissen Co., Ltd. | 2012 | — |
| +1 | K182725 | Apis | Sweetbio, Inc. | 2019 | — |
| +2 | K222143 | Apis (R), Veris (TM) | Sweetbio, Inc. | 2023 | — |
| +2 | K211972 | Omeza Collagen Matrix | Omeza, LLC | 2021 | — |
| +1 | K140456 | Bio-Connekt Wound Matrix | MLM Biologics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K090812 | Theraform Standard/SheetSummary page 2…The subject device is substantially equivalent to the following predicate devices: * TheraForm h Standard / Sheet manufactured by Sewon Cellontech (K(090812) Subject Device Predicate Device Company… | 2009 |
What descends from it? (4)
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 24 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K182725 (Sweetbio, Inc., 2019) has gone furthest, with 2 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. 2012, 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?
Collagen Wound Dressing is intended use for management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers, tunneled / undermined wounds, surgical wound (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree bums, and skin tears), draining wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112580: Collagen 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/K112580
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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