510(k) · Cleared
ClearedTheraform Standard/Sheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sewon Cellontech Co., Ltd. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jul 30, 2009 as substantially equivalent to K061407 (Tei Biosciences, Inc., 2006) after a 127-day review. Its family tree reaches back 5 generations to 1988. 5 later devices descend from it.
- Decided
- Jul 30, 2009
- Review
- 127 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K881854 (1988). 10 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 4 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 3 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 2 generations backK023778 DressskinTei Biosciences, Inc. · 2003
- 1 generation backK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- This deviceK090812 Theraform Standard/SheetSewon Cellontech Co., Ltd. · 2009
- Descendant · cites it directly · 4 of its ownK112580 Collagen Wound DressingDalim Tissen Co., Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK182725 ApisSweetbio, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK222143 Apis (R), Veris (TM)Sweetbio, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK211972 Omeza Collagen MatrixOmeza, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK140456 Bio-Connekt Wound MatrixMLM Biologics, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K112580Collagen Wound DressingDalim Tissen Co., Ltd. · 2012 · cites it directly4descendants
- K182725ApisSweetbio, Inc. · 2019 · 2 generations on2descendants
- K222143Apis (R), Veris (TM)Sweetbio, Inc. · 2023 · 3 generations on0descendants
- K211972Omeza Collagen MatrixOmeza, LLC · 2021 · 3 generations on0descendants
- K140456Bio-Connekt Wound MatrixMLM Biologics, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −4 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −3 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −2 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| −1 | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| 0 (this device) | K090812 | Theraform Standard/Sheet | Sewon Cellontech Co., Ltd. | 2009 | — |
| +1 | K112580 | Collagen Wound Dressing | Dalim Tissen Co., Ltd. | 2012 | — |
| +2 | K182725 | Apis | Sweetbio, Inc. | 2019 | — |
| +3 | K222143 | Apis (R), Veris (TM) | Sweetbio, Inc. | 2023 | — |
| +3 | K211972 | Omeza Collagen Matrix | Omeza, LLC | 2021 | — |
| +2 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K061407 | Primatrix Dermal Repair ScaffoldSummary page 2…* Draining wounds Predicate Devices The subject device is substantially equivalent to the following predicate devices: PriMatrix Dermal Repair Scaffold (K061407) manufactured by TEI BIO Sciences Inc. Comparison to Predicate Devices Comparisons have established that the subject of Thera… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112580 | Collagen Wound Dressing | 2012 | 4 |
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 21 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K112580 (Dalim Tissen Co., Ltd., 2012) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K061407.
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. 2009, 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?
TheraForm TMStandard / Sheet is intended for the management of wounds including:
* Partial and full-thickness wounds
* Pressure ulcers
* Venous ulcers
* Diabetic ulcers
* Chronic 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 bums, and skin tears)
* Draining wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090812 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090812: Theraform Standard/Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090812
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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