510(k) · Cleared
ClearedPrimatrix Dermal Repair Scaffold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tei Biosciences, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jun 29, 2006 as substantially equivalent to K023778 (Tei Biosciences, Inc., 2003) after a 38-day review. Its family tree reaches back 4 generations to 1988. 27 later devices descend from it.
- Decided
- Jun 29, 2006
- Review
- 38 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K881854 (1988). 9 ancestors in all. 27 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 3 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 2 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 1 generation backK023778 DressskinTei Biosciences, Inc. · 2003
- This deviceK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- Descendant · cites it directly · 20 of its ownK083440 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 5 of its ownK132343 Marigen Wound DressingKerecis Limited · 2013
- Descendant · 2 generations on · 5 of its ownK131286 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK090812 Theraform Standard/SheetSewon Cellontech Co., Ltd. · 2009
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K083440Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008 · cites it directly20descendants
- K100261Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · 2 generations on6descendants
- K132343Marigen Wound DressingKerecis Limited · 2013 · 2 generations on5descendants
- K131286Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2013 · 2 generations on5descendants
- K090812Theraform Standard/SheetSewon Cellontech Co., Ltd. · 2009 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −3 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −2 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −1 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| 0 (this device) | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| +1 | K083440 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2008 | — |
| +2 | K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold | Tei Biosciences, Inc. | 2010 | 3 |
| +2 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
| +2 | K131286 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2013 | — |
| +1 | K090812 | Theraform Standard/Sheet | Sewon Cellontech Co., Ltd. | 2009 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023778 | DressskinSummary page 1…ntended use to: Predicate Devices Manufacturer I 510(k) Number DressSkin TEI Biosciences IK023778 - 26 - TEl BIOSCIENCES INC. PriMa… | 2003 |
What descends from it? (27)
See all 272 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 18 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K083440 (Tei Biosciences, Inc., 2008) has gone furthest, with 20 descendants of its own.
- 3 other devices also cite its predicate K023778.
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 | — |
What is it indicated for?
PriMatrix is intended for the management of wounds that include:
• Partial and full thickness wounds
* Pressure, diabetic, and venous ulcers
* Second-degree burns
* Surgical wounds-donor sites/grafts, post-mohs surgery, post-laser surgery, podiatric, wound dehiscence
* Trauma wounds-abrasions, lacerations, and skin tears
* Tunneled/undermined wounds
* Draining wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061407 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061407: Primatrix Dermal Repair Scaffold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061407
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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