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 Nov 13, 2023 as substantially equivalent to K210949 (Bionova Medical, Inc., 2022) and 2 other predicates after a 136-day review. Its family tree reaches back 8 generations to 1997. 2 later devices descend from it.
- Decided
- Nov 13, 2023
- Review
- 136 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K973688 (1997). 76 ancestors in all, the oldest K871166 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- 7 generations backK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- 6 generations backK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- 5 generations backK040019 SilversealNoble Fiber Technologies · 2004
- 4 generations backK061227 Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2006
- 3 generations backK090160 Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009
- 2 generations backK142879 BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015
- 1 generation backK172140 NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing…Polynovo Biomaterials Pty, Ltd. · 2017
- This deviceK231937 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK240298 Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK243181 Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| −7 | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| −6 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| −5 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| −4 | K061227 | Hydrolyzed Collagen/AG Wound Gel with Silver | The Hymed Group Corp. | 2006 | — |
| −3 | K090160 | Suprathel Wound and Burn Dressing | Polymedics Innovations, GmbH | 2009 | — |
| −2 | K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015 | — |
| −1 | K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x… | Polynovo Biomaterials Pty, Ltd. | 2017 | — |
| 0 (this device) | K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2023 | — |
| +1 | K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | 2024 | — |
| +1 | 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 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 8 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K210949 | Foundation Dermal Regeneration Scaffold (DRS) SoloSummary page 5…Predicate Device Name / Manufacturer Predicate Foundation Dermal Regeneration Scaffold (DRS) Solo / BioNova K210949 Primary Medical, Inc.… | 2022 |
| * | K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Summary page 5…DRS) Solo / BioNova K210949 Primary Medical, Inc. K172140 NovoSorb BTM Wound Dressing / PolyNovo Biomaterials Pty Ltd Secondary K112888 Meso Wound Matrix / Ke… | 2017 |
| * | K112888 | Meso Wound MatrixSummary page 5…Primary Medical, Inc. K172140 NovoSorb BTM Wound Dressing / PolyNovo Biomaterials Pty Ltd Secondary K112888 Meso Wound Matrix / Kensey Nash Corporation Secondary 510(k) Number R… | 2012 |
| † | K103787 | Medeor Matrix | 2011 |
| † | K210661 | SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset | 2021 |
What descends from it? (2)
2 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 26 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 76 ancestors have a recall of any class.
- Of its descendants, K240298 (Bionova Medical, Inc., 2024) has gone furthest, with 1 descendant 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. 2023, 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
* Partial thickness burns (superficial second-degree burns)
* 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231937: Foundation Dermal Regeneration Scaffold (DRS) Solo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231937
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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