510(k) · Cleared
ClearedBonvadis®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oneness Biotech Co., Ltd. · FRO Dressing, Wound, Drug
Cleared on Jun 9, 2025 as substantially equivalent to K232655 (Stemcyte, Inc., 2024) and 1 other predicate after a 60-day review. Its family tree reaches back 8 generations to 1983. 1 later device descends from it.
- Decided
- Jun 9, 2025
- Review
- 60 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K830708 (1983). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
- 7 generations backK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
- 6 generations backK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
- 5 generations backK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
- 4 generations backK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
- 3 generations backK153648 Microcyn Plus Skin and Wound HydrogelOculus Innovative Sciences · 2016
- 2 generations backK173549 BiafineValeant Pharmaceuticals · 2018
- 1 generation backK232655 Bonvadis®Stemcyte, Inc. · 2024
- This deviceK251093 Bonvadis®Oneness Biotech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK261638 Bonvadis®Oneness Biotech Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261638Bonvadis®Oneness Biotech Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K830708 | Duo Derm Flex Hydroactive Dressings & | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| −7 | K984413 | Bionect Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| −6 | K020325 | L.a.M. Ipm Wound Gel | L.A.M. Pharmaceutical, Corp. | 2002 | — |
| −5 | K090725 | Oculus Microcyn Wound Gel | Oculus Innovative Sciences, Inc. | 2009 | — |
| −4 | K093585 | Microcyn Skin and Wound Hydrogel | Oculus Innovative Sciences, Inc. | 2010 | 1 |
| −3 | K153648 | Microcyn Plus Skin and Wound Hydrogel | Oculus Innovative Sciences | 2016 | — |
| −2 | K173549 | Biafine | Valeant Pharmaceuticals | 2018 | — |
| −1 | K232655 | Bonvadis® | Stemcyte, Inc. | 2024 | — |
| 0 (this device) | K251093 | Bonvadis® | Oneness Biotech Co., Ltd. | 2025 | — |
| +1 | K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K232655 | Bonvadis®Summary page 5…sing, Wound, Drug Common Name: Wound Dressing Product Codes: FRO Regulation Number: Unclassified 3. Predicate Devices Bonvadis Topical Cream cleared under K232655 on May 22, 2024. BIAFINE Topical Cream cleared under K173549 on Aug.13, 2018. 4. Product Description Bonvadis® is a non-s… | 2024 |
| * | K173549 | BiafineSummary page 5…s: FRO Regulation Number: Unclassified 3. Predicate Devices Bonvadis Topical Cream cleared under K232655 on May 22, 2024. BIAFINE Topical Cream cleared under K173549 on Aug.13, 2018. 4. Product Description Bonvadis® is a non-sterile water based, preserved, semi-viscous formulation, for pre… | 2018 |
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 |
|---|---|---|---|
| K261638 | Bonvadis® | 2026 | 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 42 years and passes through 8 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K261638 (Oneness Biotech Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251093 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251093: Bonvadis®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251093
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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