510(k) · Cleared
ClearedHylatopicplus Cream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Dermatology Incorporated · FRO Dressing, Wound, Drug
Cleared on Apr 1, 2011 as substantially equivalent to K093051 (Collegium Pharmaceutical Incorporated, 2009) after a 16-day review. Its family tree reaches back 6 generations to 1996. 4 later devices descend from it.
- Decided
- Apr 1, 2011
- Review
- 16 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K961758 (1996). 8 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
- 5 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
- 4 generations backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
- 3 generations backK060272 Locobase Wound and Skin EmulsionFerndale Laboratories, Inc. · 2007
- 2 generations backK083024 Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated · 2009
- 1 generation backK093051 Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 2009
- This deviceK110727 Hylatopicplus CreamPrecision Dermatology Incorporated · 2011
- Descendant · cites it directly · 0 of its ownK150914 Dash-Topic Plus CreamFounders Science Group, LLC · 2016
- Descendant · cites it directly · 0 of its ownK132329 Nivatopic PlusNivagen Pharmaceuticals, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK123678 Hyalmix CreamIgi Laboratories, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK121559 Hylatopicplus LotionPrecision Dermatology Incorporated · 2012
Most influential descendants
Showing 4 of 4 · See all- K150914Dash-Topic Plus CreamFounders Science Group, LLC · 2016 · cites it directly0descendants
- K132329Nivatopic PlusNivagen Pharmaceuticals, Inc. · 2013 · cites it directly0descendants
- K123678Hyalmix CreamIgi Laboratories, Inc. · 2013 · cites it directly0descendants
- K121559Hylatopicplus LotionPrecision Dermatology Incorporated · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961758 | Carasyn Hydrogel Wound Products | Carrington Laboratories, Inc. | 1996 | — |
| −5 | K024367 | Sinclair Wound and Skin Emulsion | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −4 | K041342 | Impruv a.I. Cream Wound and Skin Emulsion | Stiefel Laboratories, Inc. | 2005 | — |
| −3 | K060272 | Locobase Wound and Skin Emulsion | Ferndale Laboratories, Inc. | 2007 | — |
| −2 | K083024 | Hylatopic Emollient Foam | Collegium Pharmaceutical Incorporated | 2009 | — |
| −1 | K093051 | Hylatopic Plus Emollient Foam | Collegium Pharmaceutical Incorporated | 2009 | — |
| 0 (this device) | K110727 | Hylatopicplus Cream | Precision Dermatology Incorporated | 2011 | — |
| +1 | K150914 | Dash-Topic Plus Cream | Founders Science Group, LLC | 2016 | — |
| +1 | K132329 | Nivatopic Plus | Nivagen Pharmaceuticals, Inc. | 2013 | — |
| +1 | K123678 | Hyalmix Cream | Igi Laboratories, Inc. | 2013 | — |
| +1 | K121559 | Hylatopicplus Lotion | Precision Dermatology Incorporated | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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 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? (1)
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 |
|---|---|---|---|
| * | K093051 | Hylatopic Plus Emollient FoamSummary page 1…fied Product code: MGQ Devices to Which New Device is Substantially Equivalent HylatopiCTM Plus Emollient Foam cleared December 7 th, 2009 under 5 10O(k) K09305 1, from Collegium Pharmaceutical, Inc. PreCision Dermatology acquired the legal rights to 5 10(k) K09305 1 and thus PreCision has f… | 2009 |
What descends from it? (4)
4 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 15 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K150914 (Founders Science Group, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K093051.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Under the supervision of a healthcare professional, HylatopicPlus Cream 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. HylatopicPlus Cream also helps to relieve dry, waxy skin by maintaining a
moist wound & skin environment, which is beneficial to the healing process.
HylatopiePlus Cream is indicated for use in:
Atopic Dermatitis
Allergic Contact Dermatitis
Radiation Dermatitis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110727: Hylatopicplus Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110727
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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