510(k) Report

510(k) · Cleared

Cleared

Locobase Wound and Skin Emulsion

K060272510(k) TraditionalCleared Jan 12, 2007344-day reviewClass U

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

Ferndale Laboratories, Inc. · FRO Dressing, Wound, Drug

Cleared on Jan 12, 2007 as substantially equivalent to K964240 (Medix Pharmaceuticals Americas, Inc., 1997) and 2 other predicates after a 344-day review. Its family tree reaches back 3 generations to 1996. 10 later devices descend from it.

Decided
Jan 12, 2007
Review
344 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K961758 (1996). 4 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2009: 3 descendants cleared2012: 3 descendants cleared2011: 1 descendant cleared2016: 1 descendant cleared2013: 2 descendants clearedK961758 · 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. · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants K041342 · 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. · 19960
  1. Root · 3 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
  2. 2 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
  3. 1 generation backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
  4. This deviceK060272 Locobase Wound and Skin EmulsionFerndale Laboratories, Inc. · 2007
  5. Descendant · cites it directly · 8 of its ownK083024 Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated · 2009
  6. Descendant · 2 generations on · 6 of its ownK093051 Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 2009
  7. Descendant · 3 generations on · 4 of its ownK110727 Hylatopicplus CreamPrecision Dermatology Incorporated · 2011
  8. Descendant · 3 generations on · 1 of its ownK113774 HPR Plus Emollient FoamPrugen IP Holdings, Inc. · 2012
  9. Descendant · 4 generations on · 0 of its ownK150914 Dash-Topic Plus CreamFounders Science Group, LLC · 2016

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009: 32011: 12012: 32013: 22016: 1
2009high 3 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 10 · See all
  • K083024Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated · 2009 · cites it directly8descendants
  • K093051Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 2009 · 2 generations on6descendants
  • K110727Hylatopicplus CreamPrecision Dermatology Incorporated · 2011 · 3 generations on4descendants
  • K113774HPR Plus Emollient FoamPrugen IP Holdings, Inc. · 2012 · 3 generations on1descendant
  • K150914Dash-Topic Plus CreamFounders Science Group, LLC · 2016 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K961758Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc.1996—
−2K024367Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd.2003—
−1K041342Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc.2005—
0 (this device)K060272Locobase Wound and Skin EmulsionFerndale Laboratories, Inc.2007—
+1K083024Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated2009—
+2K093051Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated2009—
+3K110727Hylatopicplus CreamPrecision Dermatology Incorporated2011—
+3K113774HPR Plus Emollient FoamPrugen IP Holdings, Inc.2012—
+4K150914Dash-Topic Plus CreamFounders Science Group, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200930
201110
201230
201320
201610
FIG. 1 — Lineage of K060272, 1996–2016Source: 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
*K964240Biafine Wound Dressing Emulsion
Summary page 1
…rogel w/Drug and/or Biologic Classification Name: Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic III. PREDICATE DEVICES BiafineTM Wound Dressing Emulsion (K964240) Medix Pharmaceuticals America, Inc. Sinclair (AtopiclairTM) Wound and Skin Emulsion (K024367) Sinclair Pharmaceuticals, Ltd. Mim…
Medix Pharmaceuticals Americas, Inc.1997—
*K024367Sinclair Wound and Skin Emulsion
Summary page 1
…nd/or Biologic III. PREDICATE DEVICES BiafineTM Wound Dressing Emulsion (K964240) Medix Pharmaceuticals America, Inc. Sinclair (AtopiclairTM) Wound and Skin Emulsion (K024367) Sinclair Pharmaceuticals, Ltd. MimyXTM Cream (K041342) Stiefel Laboratories, Inc. IV. DEVICE DESCRIPTION Locobase® Wound and…
Sinclair Pharmaceuticals, Ltd.2003—
*K041342Impruv a.I. Cream Wound and Skin Emulsion
Summary page 1
…d Dressing Emulsion (K964240) Medix Pharmaceuticals America, Inc. Sinclair (AtopiclairTM) Wound and Skin Emulsion (K024367) Sinclair Pharmaceuticals, Ltd. MimyXTM Cream (K041342) Stiefel Laboratories, Inc. IV. DEVICE DESCRIPTION Locobase® Wound and Skin Emulsion is a semi-viscous emulsion/cream formulat…
Stiefel Laboratories, Inc.2005—

Also cleared against K964240: 12 other devices →

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083024Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated20098
K092297Eletone CreamFerndale Pharma Group, Inc.20090

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 11 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K083024 (Collegium Pharmaceutical Incorporated, 2009) has gone furthest, with 8 descendants of its own.
  • 12 other devices also cite its predicate K964240.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

Under the supervision of a healthcare professional, for the management and relief of burning, itching and redness associated with atopic dermatitis.

Indications for use as stated in the FDA summary.

Also cleared against K964240

12 other devices cite the same predicate.

  • K173549BiafineValeant Pharmaceuticals · 2018
  • K122595Hydropermeate Topical Emulsion, ANSWER2SKIN Sunburn Relief Cream, ANSWER2SKIN First Aid CreamDermal Life, LLC · 2013
  • K113807Dexeryl CreamPierre Fabre Medical Devices · 2012
  • K110762Avo Barrier Topical EmulsionTrigen Laboratories, Inc. · 2011
  • K110172Sonafine Wound DressingStratus Pharmaceutical · 2011
  • K093544Tropazone CRMidlothian Laboratories · 2010

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/K060272 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060272: Locobase Wound and Skin Emulsion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060272

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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