510(k) · Cleared
ClearedCorplex P / Theracor P / Allacor P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stimlabs, LLC · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Feb 2, 2024 as substantially equivalent to K200502 (Aroa Biosurgery, Ltd., 2021) after a 270-day review. Its family tree reaches back 8 generations to 1992. 3 later devices descend from it.
- Decided
- Feb 2, 2024
- Review
- 270 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921895 (1992). 38 ancestors in all, the oldest K830889 (1983). 3 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 5 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 4 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 3 generations backK021637 Acell Ubm Lyophilized Wound DressingAcell, Inc. · 2002
- 2 generations backK092096 Endoform Dermal TemplateMesynthes, Ltd. · 2010 · Recalled
- 1 generation backK200502 Myriad ParticlesAroa Biosurgery, Ltd. · 2021
- This deviceK231325 Corplex P / Theracor P / Allacor PStimlabs, LLC · 2024
- Descendant · cites it directly · 0 of its ownK253204 CatalyzeBioTissue Holdings, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253339 TheracorStimlabs, LLC · 2025
- Descendant · cites it directly · 0 of its ownK242828 Corplex P/ Theracor P/ Allacor PStimlabs, LLC · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −7 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −5 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −4 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K021637 | Acell Ubm Lyophilized Wound Dressing | Acell, Inc. | 2002 | — |
| −2 | K092096 | Endoform Dermal Template | Mesynthes, Ltd. | 2010 | 3 |
| −1 | K200502 | Myriad Particles | Aroa Biosurgery, Ltd. | 2021 | — |
| 0 (this device) | K231325 | Corplex P / Theracor P / Allacor P | Stimlabs, LLC | 2024 | — |
| +1 | K253204 | Catalyze | BioTissue Holdings, Inc. | 2026 | — |
| +1 | K253339 | Theracor | Stimlabs, LLC | 2025 | — |
| +1 | K242828 | Corplex P/ Theracor P/ Allacor P | Stimlabs, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 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 K252673 LacertaMatrixscore 15.9 · 9 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 |
|---|---|---|---|
| * | K200502 | Myriad ParticlesSummary page 4…rials Classification name: Unclassified 3. PREDICATE DEVICE: Predicate Device: Myriad Particles Manufacturer: Aroa Biosurgery, LTD K200502, KGN, Unclassified Reference Device: InnovaMatrix PD Manufacturer: Triad Life Sciences, Inc. K211902, KG… | 2021 |
| † | K211902 | InnovaMatrix PD | 2022 |
| † | K032104 | Amniolens | 2003 |
What descends from it? (3)
3 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 32 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 38 ancestors have a recall of any class.
- Of its descendants, K253204 (BioTissue Holdings, Inc., 2026) has gone furthest, with 0 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. 2024, 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?
Corplex P/Theracor P/Allacor P is indicated for use in the management of the following wounds:
• Partial and full-thickness wounds
• Pressure ulcers
• Venous ulcers
• Diabetic ulcers
• Chronic vascular ulcers
• Tunneled/undermined wounds
• Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
• Draining wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231325: Corplex P / Theracor P / Allacor P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231325
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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