510(k) · Cleared
ClearedHylatopic Emollient Foam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collegium Pharmaceutical Incorporated · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Mar 27, 2009 as substantially equivalent to K024367 (Sinclair Pharmaceuticals, Ltd., 2003) and 2 other predicates after a 169-day review. Its family tree reaches back 4 generations to 1996. 8 later devices descend from it.
- Decided
- Mar 27, 2009
- Review
- 169 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K961758 (1996). 5 ancestors in all. 8 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 backK060272 Locobase Wound and Skin EmulsionFerndale Laboratories, Inc. · 2007
- This deviceK083024 Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated · 2009
- Descendant · cites it directly · 6 of its ownK093051 Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 2009
- Descendant · 2 generations on · 4 of its ownK110727 Hylatopicplus CreamPrecision Dermatology Incorporated · 2011
- Descendant · 2 generations on · 1 of its ownK113774 HPR Plus Emollient FoamPrugen IP Holdings, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK150914 Dash-Topic Plus CreamFounders Science Group, LLC · 2016
- Descendant · 3 generations on · 0 of its ownK132329 Nivatopic PlusNivagen Pharmaceuticals, Inc. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K093051Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 2009 · cites it directly6descendants
- K110727Hylatopicplus CreamPrecision Dermatology Incorporated · 2011 · 2 generations on4descendants
- K113774HPR Plus Emollient FoamPrugen IP Holdings, Inc. · 2012 · 2 generations on1descendant
- K150914Dash-Topic Plus CreamFounders Science Group, LLC · 2016 · 3 generations on0descendants
- K132329Nivatopic PlusNivagen Pharmaceuticals, Inc. · 2013 · 3 generations on0descendants
View 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 | K060272 | Locobase Wound and Skin Emulsion | Ferndale Laboratories, Inc. | 2007 | — |
| 0 (this device) | K083024 | Hylatopic Emollient Foam | Collegium Pharmaceutical Incorporated | 2009 | — |
| +1 | K093051 | Hylatopic Plus Emollient Foam | Collegium Pharmaceutical Incorporated | 2009 | — |
| +2 | K110727 | Hylatopicplus Cream | Precision Dermatology Incorporated | 2011 | — |
| +2 | K113774 | HPR Plus Emollient Foam | Prugen IP Holdings, Inc. | 2012 | — |
| +3 | K150914 | Dash-Topic Plus Cream | Founders Science Group, LLC | 2016 | — |
| +3 | K132329 | Nivatopic Plus | Nivagen Pharmaceuticals, Inc. | 2013 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2016 | 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 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? (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 |
|---|---|---|---|
| * | K024367 | Sinclair Wound and Skin EmulsionSummary page 2…SUMMARY (Cont'd) 2.5 Devices to Which New Device is Substantially Equivalent * Sinclair (AtopiclairT M ) Wound and Skin Epnulsion approved under 510(k) K024367, from Sinclair Pharmaceuticals, Ltd. * MimyXTM Cream cleared approved 510(k) K041342, from Stiefel Laboratories… | 2003 |
| * | K041342 | Impruv a.I. Cream Wound and Skin EmulsionSummary page 2…ir (AtopiclairT M ) Wound and Skin Epnulsion approved under 510(k) K024367, from Sinclair Pharmaceuticals, Ltd. * MimyXTM Cream cleared approved 510(k) K041342, from Stiefel Laboratories, Inc. · Locobase® Wound and Skin Emulsion approved under 510(k) K060272, from Fernda… | 2005 |
| * | K060272 | Locobase Wound and Skin EmulsionSummary page 2…euticals, Ltd. * MimyXTM Cream cleared approved 510(k) K041342, from Stiefel Laboratories, Inc. · Locobase® Wound and Skin Emulsion approved under 510(k) K060272, from Ferndale Laboratories, Inc. 2.6 Device Description HylatopicTM Emollient Foam is a non-steroidal, non-s… | 2007 |
What descends from it? (8)
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 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K093051 (Collegium Pharmaceutical Incorporated, 2009) has gone furthest, with 6 descendants of its own.
- 9 other devices also cite its predicate K024367.
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. 2009, this device’s year, is highlighted.
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?
Under the supervision of a healthcare professional, HylatopicTM Emollient Foam, an aerosol-based emollient foam, is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HylatopicTM Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083024 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083024: Hylatopic Emollient Foam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083024
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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