510(k) · Cleared
ClearedUnite Biomatrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pegasus Biologics, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jun 20, 2007 as substantially equivalent to K061494 (Pegasus Biologics, Inc., 2006) after a 28-day review. Its family tree reaches back 4 generations to 1988. 25 later devices descend from it.
- Decided
- Jun 20, 2007
- Review
- 28 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K881854 (1988). 11 ancestors in all. 25 later devices descend from it, 4 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 backK040283 BiopadEuroresearch Srl · 2005
- 1 generation backK061494 Dermadapt Wound DressingPegasus Biologics, Inc. · 2006
- This deviceK071425 Unite BiomatrixPegasus Biologics, Inc. · 2007
- Descendant · cites it directly · 19 of its ownK092096 Endoform Dermal TemplateMesynthes, Ltd. · 2010 · Recalled
- Descendant · cites it directly · 7 of its ownK082103 LTM Wound DressingLifecell Corp. · 2008
- Descendant · 2 generations on · 5 of its ownK132343 Marigen Wound DressingKerecis Limited · 2013
- Descendant · 2 generations on · 4 of its ownK200502 Myriad ParticlesAroa Biosurgery, Ltd. · 2021
- Descendant · 3 generations on · 3 of its ownK231325 Corplex P / Theracor P / Allacor PStimlabs, LLC · 2024
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K092096Endoform Dermal TemplateMesynthes, Ltd. · 2010 · cites it directly19descendants
- K082103LTM Wound DressingLifecell Corp. · 2008 · cites it directly7descendants
- K132343Marigen Wound DressingKerecis Limited · 2013 · 2 generations on5descendants
- K200502Myriad ParticlesAroa Biosurgery, Ltd. · 2021 · 2 generations on4descendants
- K231325Corplex P / Theracor P / Allacor PStimlabs, LLC · 2024 · 3 generations on3descendants
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 | K040283 | Biopad | Euroresearch Srl | 2005 | — |
| −1 | K061494 | Dermadapt Wound Dressing | Pegasus Biologics, Inc. | 2006 | — |
| 0 (this device) | K071425 | Unite Biomatrix | Pegasus Biologics, Inc. | 2007 | — |
| +1 | K092096 | Endoform Dermal Template | Mesynthes, Ltd. | 2010 | 3 |
| +1 | K082103 | LTM Wound Dressing | Lifecell Corp. | 2008 | — |
| +2 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
| +2 | K200502 | Myriad Particles | Aroa Biosurgery, Ltd. | 2021 | — |
| +3 | K231325 | Corplex P / Theracor P / Allacor P | Stimlabs, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K061494 | Dermadapt Wound DressingSummary page 1…teTM Biomatrix is substantially equivalent to the DermADAPTTM Wound Dressing manufactured by Pegasus Biologics, Inc. and cleared for commercial distribution under 510(k) K061494. 11.4 DEVICE DESCRIPTION The Pegasus Biologics UniteTM Biomatrix is decellularized, equine pericardium. The UniteTM Biomatrix ha… | 2006 |
What descends from it? (25)
See all 254 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 19 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K092096 (Mesynthes, Ltd., 2010) has gone furthest, with 19 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. 2007, 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?
The Pegasus Biologics UniteTM Biomatrix is a collagen-based wound dressing for the
local management of moderately to heavy exuding wounds, including:
* Partial and full thickness wounds,
* Draining wounds,
* Pressure sores/ulcers,
* Venous ulcers,
* Chronic vascular ulcers,
* Diabetic ulcers,
* Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin
tears),
* Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs'
surgery, podiatric wounds, dehisced surgical incisions)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071425: Unite Biomatrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071425
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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