510(k) · Cleared
ClearedHPR Plus Emollient Foam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prugen IP Holdings, Inc. · FRO Dressing, Wound, Drug
Cleared on Feb 9, 2012 as substantially equivalent to K093051 (Collegium Pharmaceutical Incorporated, 2009) after a 49-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Feb 9, 2012
- Review
- 49 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. 1 later device descends from it, 1 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 deviceK113774 HPR Plus Emollient FoamPrugen IP Holdings, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK132329 Nivatopic PlusNivagen Pharmaceuticals, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132329Nivatopic PlusNivagen Pharmaceuticals, Inc. · 2013 · 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) | K113774 | HPR Plus Emollient Foam | Prugen IP Holdings, Inc. | 2012 | — |
| +1 | K132329 | Nivatopic Plus | Nivagen Pharmaceuticals, Inc. | 2013 | — |
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 |
|---|---|---|
| 2013 | 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…ings, Inc. believes that HPRTM Plus Emollient Foam is substantially equivalent to the following currently marketed device: HylatopicT M Plus Emollient Foam cleared under K093051. 4. Device Description: HPRTM Plus Emollient Foam is a non-steroidal, non-sterile, off-white, low odor, fragrance free, top… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132329 | Nivatopic Plus | 2013 | 0 |
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 16 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K132329 (Nivagen Pharmaceuticals, Inc., 2013) 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. 2012, 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?
HPRm Plus Emollient Foam is indicated to manage and relieve the burning, itching and pain associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. HPRm Plus 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/K113774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113774: HPR Plus Emollient Foam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113774
Report an extraction error
Are you the manufacturer?
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