510(k) Report

510(k) · Cleared

Cleared

Dermafine

K140905510(k) TraditionalCleared May 8, 2015394-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Invado Pharmaceuticals · FRO Dressing, Wound, Drug

Cleared on May 8, 2015 as substantially equivalent to K110172 (Stratus Pharmaceutical, 2011) and 2 other predicates after a 394-day review. Its family tree reaches back 5 generations to 1996.

Decided
May 8, 2015
Review
394 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K961758 (1996). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestorK961758 · Carasyn Hydrogel Wound Products · Carrington Laboratories, Inc. · 1996K024367 · Sinclair Wound and Skin Emulsion · Sinclair Pharmaceuticals, Ltd. · 2003K041342 · Impruv a.I. Cream Wound and Skin Emulsion · Stiefel Laboratories, Inc. · 2005K082089 · Prumyx Cream · Prugen, Inc. · 2009K110172 · Sonafine Wound Dressing · Stratus Pharmaceutical · 201119952000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor K110172 · Sonafine Wound Dressing · Stratus Pharmaceutical · 2011K082089 · Prumyx Cream · Prugen, Inc. · 2009K041342 · Impruv a.I. Cream Wound and Skin Emulsion · Stiefel Laboratories, Inc. · 2005K024367 · Sinclair Wound and Skin Emulsion · Sinclair Pharmaceuticals, Ltd. · 2003K961758 · Carasyn Hydrogel Wound Products · Carrington Laboratories, Inc. · 1996−50
  1. Root · 5 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
  2. 4 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
  3. 3 generations backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
  4. 2 generations backK082089 Prumyx CreamPrugen, Inc. · 2009
  5. 1 generation backK110172 Sonafine Wound DressingStratus Pharmaceutical · 2011
  6. This deviceK140905 DermafineInvado Pharmaceuticals · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K961758Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc.1996—
−4K024367Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd.2003—
−3K041342Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc.2005—
−2K082089Prumyx CreamPrugen, Inc.2009—
−1K110172Sonafine Wound DressingStratus Pharmaceutical2011—
0 (this device)K140905DermafineInvado Pharmaceuticals2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K140905, 1996–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K110172Sonafine Wound Dressing
Summary page 4
…Unclassified Product Code: FRO Identification of predicate devices to which substantial equivalence is being claimed: SonaFine Wound Dressing Stratus Pharmaceutical K110172 (Principal Predicate) MimyX Cream Stiefel Laboratories K041342 PruMyx Cream PruGen Pharmaceutical K082089 Description of the Dev…
Stratus Pharmaceutical2011—
*K041342Impruv a.I. Cream Wound and Skin Emulsion
Summary page 4
…evices to which substantial equivalence is being claimed: SonaFine Wound Dressing Stratus Pharmaceutical K110172 (Principal Predicate) MimyX Cream Stiefel Laboratories K041342 PruMyx Cream PruGen Pharmaceutical K082089 Description of the Device: DermaFINE Wound Dressing is a preserved emulsion intended…
Stiefel Laboratories, Inc.2005—
*K082089Prumyx Cream
Summary page 4
…being claimed: SonaFine Wound Dressing Stratus Pharmaceutical K110172 (Principal Predicate) MimyX Cream Stiefel Laboratories K041342 PruMyx Cream PruGen Pharmaceutical K082089 Description of the Device: DermaFINE Wound Dressing is a preserved emulsion intended to be used as a topically applied preparati…
Prugen, Inc.2009—

Also cleared against K110172: 1 other device →

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 19 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
  • None of the 6 ancestors has a recall.
  • 1 other device also cites its predicate K110172.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007: 292008: 262009: 312010: 312011: 272012: 242013: 192014: 222015: 282016: 282017: 232018: 202019: 162020: 122021: 82022: 92023: 182024: 242025: 112026 (partial year): 17
2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007: 187 days median2008: 130 days median2009: 136 days median2010: 146 days median2011: 177 days median2012: 96 days median2013: 194 days median2014: 214 days median2015: 249 days median2016: 222 days median2017: 147 days median2018: 206 days median2019: 270 days median2020: 226 days median2021: 275 days median2022: 332 days median2023: 283 days median2024: 263 days median2025: 176 days median2026 (partial year): 254 days median
2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007: 42008: 12009: 12011: 42013: 12014: 12015: 22016: 32017: 12019: 12021: 62022: 22023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007: 552008: 302009: 452010: 1222011: 422012: 652013: 1392014: 2692015: 2972016: 1472017: 1492018: 1282019: 1362020: 1392021: 1832022: 1762023: 1982024: 2322025: 192
2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200729187455
200826130130
200931136145
2010311460122
201127177442
20122496065
2013191941139
2014222141269
2015282492297
2016282223147
2017231471149
2018202060128
2019162701136
2020122260139
202182756183
202293322176
2023182832 (2)198
2024242632232
2025111760192
2026172542—

What is it indicated for?

Rx Indications for Use: DermaFINE 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

by maintaining a moist wound and skin environment.

OTC Indications for Use: DermaFINE Wound Dressing Emulsion is indicated for the management of minor cuts, minor burns, and minor lacerations by maintaining a moist wound and skin environment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K110172

1 other device cites the same predicate.

  • K233151PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)Medline Industries, LP · 2024

More from Invado Pharmaceuticals

2 FDA decisions under this applicant name. See the company

  • K093642NeutrasalInvado Pharmaceuticals · 2009

Recent decisions in FRO

The FRO category page

  • K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
  • K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
  • K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026

https://510kreport.com/device/K140905 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140905: Dermafine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140905

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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