510(k) · Cleared
ClearedImpruv a.I. Cream Wound and Skin Emulsion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stiefel Laboratories, Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Jul 19, 2005 as substantially equivalent to K964240 (Medix Pharmaceuticals Americas, Inc., 1997) and 1 other predicate after a 425-day review. Its family tree reaches back 2 generations to 1996. 44 later devices descend from it.
- Decided
- Jul 19, 2005
- Review
- 425 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961758 (1996). 3 ancestors in all. 44 later devices descend from it, 17 citing it directly.
- Root · 2 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
- 1 generation backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
- This deviceK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
- Descendant · cites it directly · 16 of its ownK052643 EpiceramCeragenix Corporation · 2006
- Descendant · cites it directly · 10 of its ownK060272 Locobase Wound and Skin EmulsionFerndale Laboratories, Inc. · 2007
- Descendant · cites it directly · 8 of its ownK083024 Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated · 2009
- Descendant · cites it directly · 7 of its ownK073246 ZenievaGorbec Pharmaceutical Services, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK093051 Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 2009
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K052643EpiceramCeragenix Corporation · 2006 · cites it directly16descendants
- K060272Locobase Wound and Skin EmulsionFerndale Laboratories, Inc. · 2007 · cites it directly10descendants
- K083024Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated · 2009 · cites it directly8descendants
- K073246ZenievaGorbec Pharmaceutical Services, Inc. · 2008 · cites it directly7descendants
- K093051Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 2009 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961758 | Carasyn Hydrogel Wound Products | Carrington Laboratories, Inc. | 1996 | — |
| −1 | K024367 | Sinclair Wound and Skin Emulsion | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| 0 (this device) | K041342 | Impruv a.I. Cream Wound and Skin Emulsion | Stiefel Laboratories, Inc. | 2005 | — |
| +1 | K052643 | Epiceram | Ceragenix Corporation | 2006 | — |
| +1 | K060272 | Locobase Wound and Skin Emulsion | Ferndale Laboratories, Inc. | 2007 | — |
| +1 | K083024 | Hylatopic Emollient Foam | Collegium Pharmaceutical Incorporated | 2009 | — |
| +1 | K073246 | Zenieva | Gorbec Pharmaceutical Services, Inc. | 2008 | — |
| +1 | K093051 | Hylatopic Plus Emollient Foam | Collegium Pharmaceutical Incorporated | 2009 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 MGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K964240 | Biafine Wound Dressing EmulsionSummary page 1…Cream is substantially equivalent to the currently marketed devices, Biafine® Wound Dressing Emulsion (Radiodermatitis Emulsion) cleared under K964240 and Sinclair Wound and Skin Emulsion cleared under K024367. 4. Device Description: MimyX TM… | 1997 |
| * | K024367 | Sinclair Wound and Skin EmulsionSummary page 1…d devices, Biafine® Wound Dressing Emulsion (Radiodermatitis Emulsion) cleared under K964240 and Sinclair Wound and Skin Emulsion cleared under K024367. 4. Device Description: MimyX TM Cream is a non-sterile, semi-viscous emulsion intended for topical… | 2003 |
What descends from it? (44)
See all 4417 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052643 | Epiceram | 2006 | 16 |
| K060272 | Locobase Wound and Skin Emulsion | 2007 | 10 |
| K083024 | Hylatopic Emollient Foam | 2009 | 8 |
| K073246 | Zenieva | 2008 | 7 |
| K093051 | Hylatopic Plus Emollient Foam | 2009 | 6 |
| K070309 | Neosalus | 2008 | 5 |
| K090337 | Tropazone Lotion | 2009 | 3 |
| K082089 | Prumyx Cream | 2009 | 3 |
| K110172 | Sonafine Wound Dressing | 2011 | 2 |
| K071483 | Tetrix Cream | 2008 | 2 |
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 9 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K052643 (Ceragenix Corporation, 2006) has gone furthest, with 16 descendants of its own.
- 12 other devices also cite its predicate K964240.
How does its category compare?
All MGQ devicesMGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MGQ
Too few MGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGQ
4in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 2025
MAUDE reports naming product code MGQ, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 4 | 10 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
FOR TOPICAL DERMATOLOGICAL USE ONLY Description Rx Product: Under the supervision of a healthcare professional, MimyX Cream is indicated to manage and relieve the burning and itching experienced with various-types of denmatoses, including radiation dermatitis, atopic dennatitis and allergic contact dermatitis. MirnyX Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.…
Read the full statement (138 words)
FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
Under the supervision of a healthcare professional, MimyX Cream is indicated to manage and relieve the burning and itching experienced with various-types of denmatoses, including radiation dermatitis, atopic dennatitis and allergic contact dermatitis. MirnyX Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Directions for Use (Rx and OTC):
Apply MimyX Cream to the affected skin areas 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover MimyX Cream with a dressing of choice.
Description OTC Product:
MirnyX Cream helps to nourish skin and relieve theburning and itching associated with many common types of skin irritation. MimyX Cream may also be used to soothe minor bums, including sunburn.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041342: Impruv a.I. Cream Wound and Skin Emulsion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041342
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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