510(k) · Cleared
ClearedBiafine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valeant Pharmaceuticals · FRO Dressing, Wound, Drug
Cleared on Aug 13, 2018 as substantially equivalent to K964240 (Medix Pharmaceuticals Americas, Inc., 1997) and 2 other predicates after a 270-day review. Its family tree reaches back 6 generations to 1983. 4 later devices descend from it.
- Decided
- Aug 13, 2018
- Review
- 270 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K830708 (1983). 15 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
- 5 generations backK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
- 4 generations backK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
- 3 generations backK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
- 2 generations backK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
- 1 generation backK153648 Microcyn Plus Skin and Wound HydrogelOculus Innovative Sciences · 2016
- This deviceK173549 BiafineValeant Pharmaceuticals · 2018
- Descendant · cites it directly · 2 of its ownK232655 Bonvadis®Stemcyte, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK251093 Bonvadis®Oneness Biotech Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK261638 Bonvadis®Oneness Biotech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK190342 BIAFINE Topical CreamBausch Health Americas Incorporated · 2019
Most influential descendants
Showing 4 of 4 · See all- K232655Bonvadis®Stemcyte, Inc. · 2024 · cites it directly2descendants
- K251093Bonvadis®Oneness Biotech Co., Ltd. · 2025 · cites it directly1descendant
- K261638Bonvadis®Oneness Biotech Co., Ltd. · 2026 · 2 generations on0descendants
- K190342BIAFINE Topical CreamBausch Health Americas Incorporated · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K830708 | Duo Derm Flex Hydroactive Dressings & | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| −5 | K984413 | Bionect Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| −4 | K020325 | L.a.M. Ipm Wound Gel | L.A.M. Pharmaceutical, Corp. | 2002 | — |
| −3 | K090725 | Oculus Microcyn Wound Gel | Oculus Innovative Sciences, Inc. | 2009 | — |
| −2 | K093585 | Microcyn Skin and Wound Hydrogel | Oculus Innovative Sciences, Inc. | 2010 | 1 |
| −1 | K153648 | Microcyn Plus Skin and Wound Hydrogel | Oculus Innovative Sciences | 2016 | — |
| 0 (this device) | K173549 | Biafine | Valeant Pharmaceuticals | 2018 | — |
| +1 | K232655 | Bonvadis® | Stemcyte, Inc. | 2024 | — |
| +1 | K251093 | Bonvadis® | Oneness Biotech Co., Ltd. | 2025 | — |
| +2 | K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | 2026 | — |
| +1 | K190342 | BIAFINE Topical Cream | Bausch Health Americas Incorporated | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K964240 | Biafine Wound Dressing EmulsionSummary page 4…No performance standards for this device have been promulgated under Section 514, Federal Food, Drug and Cosmetics Act. 3. Predicate Devices BIAFINE cleared under K964240 on January 22, 1997 Microcyn Plus Skin and Wound Hydrogel cleared under K153648 on April 19, 2016. Sockit Dermal Gel cleared unde… | 1997 |
| * | K153648 | Microcyn Plus Skin and Wound HydrogelSummary page 4…on 514, Federal Food, Drug and Cosmetics Act. 3. Predicate Devices BIAFINE cleared under K964240 on January 22, 1997 Microcyn Plus Skin and Wound Hydrogel cleared under K153648 on April 19, 2016. Sockit Dermal Gel cleared under K090092 on May 11, 2009 Reference Device OxyBand cleared under K043063 on Mar… | 2016 |
| * | K090092 | Sockit! and Mcmerlin Dermal Wound GelSummary page 4…Devices BIAFINE cleared under K964240 on January 22, 1997 Microcyn Plus Skin and Wound Hydrogel cleared under K153648 on April 19, 2016. Sockit Dermal Gel cleared under K090092 on May 11, 2009 Reference Device OxyBand cleared under K043063 on March 24, 2005 4. Product Description The subject of this 510… | 2009 |
| † | K043063 | Oxyband Wound Dressing | 2005 |
What descends from it? (4)
3 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 35 years and passes through 6 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K232655 (Stemcyte, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K964240.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
OTC Indications and Usage: BIAFINE is indicated for management of superficial wounds such as minor cuts, minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns including sunburns, minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions…
Read the full statement (116 words)
OTC Indications and Usage:
BIAFINE is indicated for management of superficial wounds such as minor cuts, minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns including sunburns, minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels.
BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions and minor burns.
RX Indications and Usage:
BIAFINE is indicated for management of full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers, radiation dermatitis, donor sites and 2nd degree burns.
BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions and minor burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173549 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173549: Biafine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173549
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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