510(k) · Cleared
ClearedHexagen Derm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Health Solutions, LLC · FRO Dressing, Wound, Drug
Cleared on Aug 25, 2017 as substantially equivalent to K160872 (Global Health Solutions, LLC, 2016) and 1 other predicate after a 123-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Aug 25, 2017
- Review
- 123 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K961758 (1996). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 backK052643 EpiceramCeragenix Corporation · 2006
- This deviceK171191 Hexagen DermGlobal Health Solutions, LLC · 2017
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 | K052643 | Epiceram | Ceragenix Corporation | 2006 | — |
| 0 (this device) | K171191 | Hexagen Derm | Global Health Solutions, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 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? (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 |
|---|---|---|---|
| * | K160872 | PolyPlex Wound DressingSummary page 4…Derm Common Name: Topical Emulsion Classification Name: Dressing, Wound, Drug Product Code: FRO Device Class: Unclassified 5. Predicate Device: PolyPlex Wound Dressing (K160872) Epiceram Skin Barrier Emulsion (K052643) 6. Description of Proposed Device: Hexagen Derm is an amorphous, odorless, petrolatum… | 2016 |
| * | K052643 | EpiceramSummary page 4…ification Name: Dressing, Wound, Drug Product Code: FRO Device Class: Unclassified 5. Predicate Device: PolyPlex Wound Dressing (K160872) Epiceram Skin Barrier Emulsion (K052643) 6. Description of Proposed Device: Hexagen Derm is an amorphous, odorless, petrolatum-based emollient consisting of petrolatum… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 5 companies; a new generation was cleared every 7.0 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K160872.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Hexagen Derm is a topical emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. Hexagen Derm helps to relieve dry skin conditions and manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. Hexagen Derm helps to 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/K171191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171191: Hexagen Derm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171191
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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