510(k) · Cleared
ClearedTropazone Lotion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midlothian Laboratories · FRO Dressing, Wound, Drug
Cleared on Aug 13, 2009 as substantially equivalent to K041342 (Stiefel Laboratories, Inc., 2005) and 2 other predicates after a 184-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it.
- Decided
- Aug 13, 2009
- Review
- 184 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. 3 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 backK073246 ZenievaGorbec Pharmaceutical Services, Inc. · 2008
- This deviceK090337 Tropazone LotionMidlothian Laboratories · 2009
- Descendant · cites it directly · 1 of its ownK093544 Tropazone CRMidlothian Laboratories · 2010
- Descendant · cites it directly · 0 of its ownK162217 LOYONOculus Innovative Sciences · 2017
- Descendant · 2 generations on · 0 of its ownK113807 Dexeryl CreamPierre Fabre Medical Devices · 2012
Most influential descendants
Showing 3 of 3 · 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 | K073246 | Zenieva | Gorbec Pharmaceutical Services, Inc. | 2008 | — |
| 0 (this device) | K090337 | Tropazone Lotion | Midlothian Laboratories | 2009 | — |
| +1 | K093544 | Tropazone CR | Midlothian Laboratories | 2010 | — |
| +1 | K162217 | LOYON | Oculus Innovative Sciences | 2017 | — |
| +2 | K113807 | Dexeryl Cream | Pierre Fabre Medical Devices | 2012 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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…FRO Substantial Equivalence/ Predicate Device Tropazone Lotion issubstantially equivalent to the currently marketed devices, MimyX cream, cleared under K041342, Zenieva cleared under K073246 and Biafine cleared under K964240. Device Description Tropazone Lotion isa non-sterile, semi-vis… | 2005 |
| * | K073246 | ZenievaSummary page 1…redicate Device Tropazone Lotion issubstantially equivalent to the currently marketed devices, MimyX cream, cleared under K041342, Zenieva cleared under K073246 and Biafine cleared under K964240. Device Description Tropazone Lotion isa non-sterile, semi-viscous emulsion intended for topi… | 2008 |
| * | K964240 | Biafine Wound Dressing EmulsionSummary page 1…Lotion issubstantially equivalent to the currently marketed devices, MimyX cream, cleared under K041342, Zenieva cleared under K073246 and Biafine cleared under K964240. Device Description Tropazone Lotion isa non-sterile, semi-viscous emulsion intended for topical application. It ispresented fo… | 1997 |
What descends from it? (3)
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 13 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K093544 (Midlothian Laboratories, 2010) has gone furthest, with 1 descendant 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. 2009, 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?
Tropazone Lotion is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. It helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090337: Tropazone Lotion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090337
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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