510(k) · Cleared
ClearedFoundation Dermal Regeneration Scaffold Plus (DRS+) Solo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionova Medical, Inc. · FRO Dressing, Wound, Drug
Cleared on Oct 31, 2024 as substantially equivalent to K240298 (Bionova Medical, Inc., 2024) and 1 other predicate after a 31-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Oct 31, 2024
- Review
- 31 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K973688 (1997). 78 ancestors in all, the oldest K871166 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- 6 generations between
- 3 generations backK172140 NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing…Polynovo Biomaterials Pty, Ltd. · 2017
- 2 generations backK231937 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023
- 1 generation backK240298 Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024
- This deviceK243181 Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- 9 generations backK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- 8 generations backK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- 7 generations backK040019 SilversealNoble Fiber Technologies · 2004
- 6 generations backK061227 Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2006
- 5 generations backK090160 Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009
- 4 generations backK142879 BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015
- 3 generations backK172140 NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing…Polynovo Biomaterials Pty, Ltd. · 2017
- 2 generations backK231937 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023
- 1 generation backK240298 Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024
- This deviceK243181 Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| −9 | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| −8 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| −7 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| −6 | K061227 | Hydrolyzed Collagen/AG Wound Gel with Silver | The Hymed Group Corp. | 2006 | — |
| −5 | K090160 | Suprathel Wound and Burn Dressing | Polymedics Innovations, GmbH | 2009 | — |
| −4 | K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015 | — |
| −3 | K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x… | Polynovo Biomaterials Pty, Ltd. | 2017 | — |
| −2 | K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2023 | — |
| −1 | K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | 2024 | — |
| 0 (this device) | 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 |
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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoSummary page 5…0(k) Number Predicate Device Name / Manufacturer Predicate Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo / K240298 Primary Bionova Medical, Inc.… | 2024 |
| * | K231937 | Foundation Dermal Regeneration Scaffold (DRS) SoloSummary page 5…Primary Bionova Medical, Inc. Foundation Dermal Regeneration Scaffold (DRS) Solo / Bionova K231937 Secondary Medical, Inc.… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 78 ancestors have a recall of any class.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
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 burns
• 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 as stated in the FDA summary.
https://510kreport.com/device/K243181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243181: Foundation Dermal Regeneration Scaffold Plus (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/K243181
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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