510(k) · Cleared
ClearedSonafine Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stratus Pharmaceutical · FRO Dressing, Wound, Drug
Cleared on Aug 19, 2011 as substantially equivalent to K041342 (Stiefel Laboratories, Inc., 2005) and 2 other predicates after a 211-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 211 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K961758 (1996). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
- 3 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
- 2 generations backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
- 1 generation backK082089 Prumyx CreamPrugen, Inc. · 2009
- This deviceK110172 Sonafine Wound DressingStratus Pharmaceutical · 2011
- Descendant · cites it directly · 0 of its ownK233151 PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and…Medline Industries, LP · 2024
- Descendant · cites it directly · 0 of its ownK140905 DermafineInvado Pharmaceuticals · 2015
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 |
|---|---|---|---|---|---|
| −4 | K961758 | Carasyn Hydrogel Wound Products | Carrington Laboratories, Inc. | 1996 | — |
| −3 | K024367 | Sinclair Wound and Skin Emulsion | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −2 | K041342 | Impruv a.I. Cream Wound and Skin Emulsion | Stiefel Laboratories, Inc. | 2005 | — |
| −1 | K082089 | Prumyx Cream | Prugen, Inc. | 2009 | — |
| 0 (this device) | K110172 | Sonafine Wound Dressing | Stratus Pharmaceutical | 2011 | — |
| +1 | K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound… | Medline Industries, LP | 2024 | — |
| +1 | K140905 | Dermafine | Invado Pharmaceuticals | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K041342 | Impruv a.I. Cream Wound and Skin EmulsionSummary page 1…ode: MGQ * Identification of predicate devices to which substantial equivalence is being claimed o MimyX T m Cream Stiefel Laboratories K04 1342 o BIAFIINE® Medix Pharma K964240 Wound Dressing Emulsion o Pru… | 2005 |
| * | K964240 | Biafine Wound Dressing EmulsionSummary page 1…alence is being claimed o MimyX T m Cream Stiefel Laboratories K04 1342 o BIAFIINE® Medix Pharma K964240 Wound Dressing Emulsion o PruMyXTM Cream PruGen Inc. K082089 " Descript… | 1997 |
| * | K082089 | Prumyx CreamSummary page 1…o BIAFIINE® Medix Pharma K964240 Wound Dressing Emulsion o PruMyXTM Cream PruGen Inc. K082089 " Description of the Device: SONAFINEO) Wound Dressing is a preserved emulsion intended to be used as a topically ap… | 2009 |
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 15 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K233151 (Medline Industries, LP, 2024) has gone furthest, with 0 descendants of its own.
- 16 other devices also cite its predicate K041342.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
SONAFINE® Wound Dressing is indicated for topical use in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites to include:
Radiation Dermatitis
Various types of dermatoses
Atopic dermatitis
Allergic contact dermatitis
Dry waxy skin
SONAFINE® Wound Dressing maintains a moist wound and skin environment.
SONAFINE® Wound Dressing is indicated for the management of minor cuts, minor burns, and minor lacerations.
SONAFINE® Wound Dressing maintains a moist wound and skin environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110172: Sonafine Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110172
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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