510(k) · Cleared
ClearedFoundation Dermal Regeneration Scaffold (DRS) Solo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionova Medical, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Aug 11, 2022 as substantially equivalent to K123961 (Bionova Medical, Inc., 2013) after a 499-day review. Its family tree reaches back 6 generations to 1992. 3 later devices descend from it.
- Decided
- Aug 11, 2022
- Review
- 499 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K914579 (1992). 42 ancestors in all, the oldest K871166 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 3 generations backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- 2 generations backK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- 1 generation backK123961 Sentrex Biosponge MPDBionova Medical, Inc. · 2013
- This deviceK210949 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK231937 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK240298 Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK243181 Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See all- K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023 · cites it directly2descendants
- K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024 · 2 generations on1descendant
- K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −5 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −4 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −3 | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| −2 | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | Coloplast Corp. | 2004 | — |
| −1 | K123961 | Sentrex Biosponge MPD | Bionova Medical, Inc. | 2013 | — |
| 0 (this device) | K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2022 | — |
| +1 | K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2023 | — |
| +2 | K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | 2024 | — |
| +2 | K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | Bionova Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K123961 | Sentrex Biosponge MPDSummary page 4…ion Scaffold (DRS) Solo Common Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Codes: FRO Predicate Devices: • Primary predicate: K123961, Sentrex BioSponge MPD (Bionova Medical, Inc.) • Reference Device: K081635, Integra Meshed Bilayer Wound Matrix (I… | 2013 |
| † | K081635 | Integra Meshed Bilayer Wound Matrix | 2008 |
| † | K021792 | Bilayer Matrix Wound Dressing | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | 2023 | 2 |
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 4.6 years on median.
- 2 of the 42 ancestors have a recall of any class.
- Of its descendants, K231937 (Bionova Medical, Inc., 2023) has gone furthest, with 2 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. 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?
Foundation DRS Solo is indicated for the management of wounds including:
* Full thickness and partial thickness wounds
* Pressure ulcers
* Venous ulcers
* Ulcers caused by mixed vascular etiologies
* Diabetic ulcers
* First degree bums
* Partial thickness bums (superficial second-degree bums)
* Donor sites and other bleeding surface wounds
* Abrasions
* Trauma wounds (abrasions, lacerations, skin tears)
* Dehisced wounds
* Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
Foundation DRS Solo may be cut to size.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210949: Foundation Dermal Regeneration Scaffold (DRS) Solo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210949
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