510(k) Report

510(k) · Cleared

Cleared

Tropazone CR

K093544510(k) TraditionalCleared Feb 16, 201091-day reviewClass U

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

Midlothian Laboratories · FRO Dressing, Wound, Drug

Cleared on Feb 16, 2010 as substantially equivalent to K964240 (Medix Pharmaceuticals Americas, Inc., 1997) and 3 other predicates after a 91-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.

Decided
Feb 16, 2010
Review
91 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K961758 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2012: 1 descendant 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. · 2005K073246 · Zenieva · Gorbec Pharmaceutical Services, Inc. · 2008K090337 · Tropazone Lotion · Midlothian Laboratories · 20091995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant K090337 · 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 · 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 backK073246 ZenievaGorbec Pharmaceutical Services, Inc. · 2008
  5. 1 generation backK090337 Tropazone LotionMidlothian Laboratories · 2009
  6. This deviceK093544 Tropazone CRMidlothian Laboratories · 2010
  7. Descendant · cites it directly · 0 of its ownK113807 Dexeryl CreamPierre Fabre Medical Devices · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K113807Dexeryl CreamPierre Fabre Medical Devices · 2012 · cites it directly0descendants
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—
−2K073246ZenievaGorbec Pharmaceutical Services, Inc.2008—
−1K090337Tropazone LotionMidlothian Laboratories2009—
0 (this device)K093544Tropazone CRMidlothian Laboratories2010—
+1K113807Dexeryl CreamPierre Fabre Medical Devices2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K093544, 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
Get a 510(k) Report

What was it cleared against? (4)

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
…oduct Code: Substantial EquivalencelPredicate Device: Tropazone CR is substantially equivalent to the currently marketed device Biafine cleared under application number K964240, Tropazone Lotion cleared under application number K090337, MimyX cream, cleared under application number K04 1342 and Zenieva, c…
Medix Pharmaceuticals Americas, Inc.1997—
*K090337Tropazone Lotion
Summary page 1
…azone CR is substantially equivalent to the currently marketed device Biafine cleared under application number K964240, Tropazone Lotion cleared under application number K090337, MimyX cream, cleared under application number K04 1342 and Zenieva, cleared under application number K073246. Device Descriptio…
Midlothian Laboratories2009—
*K041342Impruv a.I. Cream Wound and Skin Emulsion
Summary page 1
…arketed device Biafine cleared under application number K964240, Tropazone Lotion cleared under application number K090337, MimyX cream, cleared under application number K04 1342 and Zenieva, cleared under application number K073246. Device Description: Tropazone CR is a non-sterile, semi-viscous emulsion…
Stiefel Laboratories, Inc.2005—
*K073246Zenieva
Summary page 1
…K964240, Tropazone Lotion cleared under application number K090337, MimyX cream, cleared under application number K04 1342 and Zenieva, cleared under application number K073246. Device Description: Tropazone CR is a non-sterile, semi-viscous emulsion intended for topical application. It is presented as a…
Gorbec Pharmaceutical Services, Inc.2008—

Also cleared against K964240: 12 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113807Dexeryl CreamPierre Fabre Medical Devices20120

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 14 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K113807 (Pierre Fabre Medical Devices, 2012) has gone furthest, with 0 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. 2010, 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?

Tropazone CR is for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation 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
  • K092878Prutect Topical Ointment, Models 45 Gram Tube, 90 Gram TubePrugen IP Holdings, Inc. · 2010

More from Midlothian Laboratories

2 FDA decisions under this applicant name. See the company

  • K090337Tropazone LotionMidlothian Laboratories · 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/K093544 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093544: Tropazone CR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093544

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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