510(k) Report

510(k) · Cleared

Cleared

Dexeryl Cream

K113807510(k) TraditionalCleared Mar 7, 201275-day reviewClass U

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

Pierre Fabre Medical Devices · FRO Dressing, Wound, Drug

Cleared on Mar 7, 2012 as substantially equivalent to K093544 (Midlothian Laboratories, 2010) and 4 other predicates after a 75-day review. Its family tree reaches back 6 generations to 1996.

Decided
Mar 7, 2012
Review
75 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K961758 (1996). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2008: 2 other ancestors2006: 1 other ancestor1997: 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. · 2005K073246 · Zenieva · Gorbec Pharmaceutical Services, Inc. · 2008K090337 · Tropazone Lotion · Midlothian Laboratories · 2009K093544 · Tropazone CR · Midlothian Laboratories · 20101995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor K093544 · Tropazone CR · Midlothian Laboratories · 2010K090337 · Tropazone Lotion · Midlothian Laboratories · 2009K073246 · Zenieva · Gorbec Pharmaceutical Services, Inc. · 2008K041342 · 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 · 6 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
  2. 5 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
  3. 4 generations backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
  4. 3 generations backK073246 ZenievaGorbec Pharmaceutical Services, Inc. · 2008
  5. 2 generations backK090337 Tropazone LotionMidlothian Laboratories · 2009
  6. 1 generation backK093544 Tropazone CRMidlothian Laboratories · 2010
  7. This deviceK113807 Dexeryl CreamPierre Fabre Medical Devices · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K961758Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc.1996—
−5K024367Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd.2003—
−4K041342Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc.2005—
−3K073246ZenievaGorbec Pharmaceutical Services, Inc.2008—
−2K090337Tropazone LotionMidlothian Laboratories2009—
−1K093544Tropazone CRMidlothian Laboratories2010—
0 (this device)K113807Dexeryl CreamPierre Fabre Medical Devices2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200610
200820
200910
FIG. 1 — Lineage of K113807, 1996–2012Source: 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
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What was it cleared against? (5)

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
*K093544Tropazone CR
Summary page 1
…ERYLTM Cream is substantially equivalent in composition and intended use to the following legally marketed devices in commercial distribution: * Ttopazone Cream (K093 544), * Neosalus (K090585), * Tetrix Cream (K07 1483), * EpiCeram (K052643) and * Biafine (K964240).…
Midlothian Laboratories2010—
*K090585Neosalus Cream
Summary page 1
…quivalent in composition and intended use to the following legally marketed devices in commercial distribution: * Ttopazone Cream (K093 544), * Neosalus (K090585), * Tetrix Cream (K07 1483), * EpiCeram (K052643) and * Biafine (K964240). DEVICE DESCRIPTION DEXERYLTM…
Quinnova Pharmaceuticals2009—
*K071483Tetrix Cream
Summary page 1
…ded use to the following legally marketed devices in commercial distribution: * Ttopazone Cream (K093 544), * Neosalus (K090585), * Tetrix Cream (K07 1483), * EpiCeram (K052643) and * Biafine (K964240). DEVICE DESCRIPTION DEXERYLTM Cream is a clean but non-sterile s…
Coria Laboratories, Ltd.2008—
*K052643Epiceram
Summary page 1
…y marketed devices in commercial distribution: * Ttopazone Cream (K093 544), * Neosalus (K090585), * Tetrix Cream (K07 1483), * EpiCeram (K052643) and * Biafine (K964240). DEVICE DESCRIPTION DEXERYLTM Cream is a clean but non-sterile skin emollient designed to prov…
Ceragenix Corporation2006—
*K964240Biafine Wound Dressing Emulsion
Summary page 1
…distribution: * Ttopazone Cream (K093 544), * Neosalus (K090585), * Tetrix Cream (K07 1483), * EpiCeram (K052643) and * Biafine (K964240). DEVICE DESCRIPTION DEXERYLTM Cream is a clean but non-sterile skin emollient designed to provide protection and a moist envir…
Medix Pharmaceuticals Americas, Inc.1997—

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 16 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
  • None of the 11 ancestors has a recall.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?

DEXERYLTM Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. DEXERYLTM Cream provides a moist environment, which is beneficial to the healing process.

Indications for use as stated in the FDA summary.

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/K113807 · printed Nov 3, 2026

Cite this page

510(k) Report. “K113807: Dexeryl Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113807

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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