510(k) · Cleared
ClearedKerecis Silicone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerecis Limited · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jun 29, 2022 as substantially equivalent to K190528 (Kerecis Limited, 2019) after a 272-day review. Its family tree reaches back 9 generations to 1992. 1 later device descends from it.
- Decided
- Jun 29, 2022
- Review
- 272 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K921895 (1992). 65 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations between
- 3 generations backK082103 LTM Wound DressingLifecell Corp. · 2008
- 2 generations backK132343 Marigen Wound DressingKerecis Limited · 2013
- 1 generation backK190528 MariGen Wound ExtraKerecis Limited · 2019
- This deviceK213231 Kerecis SiliconeKerecis Limited · 2022
- Descendant · cites it directly · 0 of its ownK251845 Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited · 2025
Show all 9 generations
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 6 generations backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- 5 generations backK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
- 4 generations backK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
- 3 generations backK082103 LTM Wound DressingLifecell Corp. · 2008
- 2 generations backK132343 Marigen Wound DressingKerecis Limited · 2013
- 1 generation backK190528 MariGen Wound ExtraKerecis Limited · 2019
- This deviceK213231 Kerecis SiliconeKerecis Limited · 2022
Most influential descendants
Showing 1 of 1 · See all- K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −8 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −6 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| −5 | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece… | Tissue Science Laboratories, Plc | 2005 | — |
| −4 | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | 2 |
| −3 | K082103 | LTM Wound Dressing | Lifecell Corp. | 2008 | — |
| −2 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
| −1 | K190528 | MariGen Wound Extra | Kerecis Limited | 2019 | — |
| 0 (this device) | K213231 | Kerecis Silicone | Kerecis Limited | 2022 | — |
| +1 | K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited | 2025 | — |
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 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 8 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K190528 | MariGen Wound ExtraSummary page 4…nd Collagen Classification Name: Unclassified Product code: KGN 3. PREDICATE DEVICES • Kerecis Marigen Wound Extra K190528 Predicate Device • PELNAC™ Bilayer Wound Matrix K191992 Reference Device 4. DEVICE… | 2019 |
| † | K191992 | PELNAC Bilayer Wound Matrix | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | 2025 | 0 |
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 30 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 65 ancestors have a recall of any class.
- Of its descendants, K251845 (Kerecis Limited, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K190528.
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. 2022, 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?
Kerecis Silicone is indicated for the management of wounds including:
* Partial and full-thickness wounds
* Pressure ulcers
* Venous ulcers
* Chronic vascular ulcers
* Diabetic ulcers
* Trauma wounds (abrasions, lacerations, partial-thickness bums, skin tears)
* Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
* Draining Wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213231: Kerecis Silicone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213231
Report an extraction error
Are you the manufacturer?
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