510(k) · Cleared
ClearedSinclair Seborrhea Emulsion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sinclair Pharmaceuticals, Ltd. · FRO Dressing, Wound, Drug
Cleared on Oct 11, 2006 as substantially equivalent to K024367 (Sinclair Pharmaceuticals, Ltd., 2003) after a 624-day review. Its family tree reaches back 2 generations to 1996. 9 later devices descend from it.
- Decided
- Oct 11, 2006
- Review
- 624 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961758 (1996). 3 ancestors in all. 9 later devices descend from it, 5 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 deviceK050158 Sinclair Seborrhea EmulsionSinclair Pharmaceuticals, Ltd. · 2006
- Descendant · cites it directly · 5 of its ownK111168 Precision Skin EmulsionPrecision Dermatology Incorporated · 2011
- Descendant · cites it directly · 4 of its ownK123724 Dermiseb CreamIgi Laboratories, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK120730 Loutrex Topical CreamAcella Pharmaceuticals, LLC · 2012
- Descendant · cites it directly · 4 of its ownK121134 TL Triseb CreamTrigen Laboratories, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK152945 Alevicyn SG Antipruritic GelOculus Innovative Sciences · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K111168Precision Skin EmulsionPrecision Dermatology Incorporated · 2011 · cites it directly5descendants
- K123724Dermiseb CreamIgi Laboratories, Inc. · 2013 · cites it directly4descendants
- K120730Loutrex Topical CreamAcella Pharmaceuticals, LLC · 2012 · cites it directly4descendants
- K121134TL Triseb CreamTrigen Laboratories, Inc. · 2012 · cites it directly4descendants
- K152945Alevicyn SG Antipruritic GelOculus Innovative Sciences · 2015 · 2 generations on3descendants
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) | K050158 | Sinclair Seborrhea Emulsion | Sinclair Pharmaceuticals, Ltd. | 2006 | — |
| +1 | K111168 | Precision Skin Emulsion | Precision Dermatology Incorporated | 2011 | — |
| +1 | K123724 | Dermiseb Cream | Igi Laboratories, Inc. | 2013 | — |
| +1 | K120730 | Loutrex Topical Cream | Acella Pharmaceuticals, LLC | 2012 | — |
| +1 | K121134 | TL Triseb Cream | Trigen Laboratories, Inc. | 2012 | — |
| +2 | K152945 | Alevicyn SG Antipruritic Gel | Oculus Innovative Sciences | 2015 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K024367 | Sinclair Wound and Skin EmulsionSummary page 1…w/Drug or Biologic 3. Devices to Which New Device is Substantially Equivalent: * Sinclair Wound and Skin Emulsion 510(k) K024367 4. Device Description: Sinclair Skin Emulsion is a non sterile viscous emulsion / gel formulation, which is presented for… | 2003 |
What descends from it? (9)
5 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 10 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K111168 (Precision Dermatology Incorporated, 2011) has gone furthest, with 5 descendants of its own.
- 9 other devices also cite its predicate K024367.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
FOR TOPICAL DERMATOLOGICAL USE ONLY Description Rx Product: Under the supervision of a healthcare professional, Sinclair Skin Emulsion is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Sinclair Skin Emulsion 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)…
Read the full statement (132 words)
FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
Under the supervision of a healthcare professional, Sinclair Skin Emulsion is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Sinclair Skin Emulsion 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 Sinclair Skin Emulsion to the affected skin areas 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover Sinclair Skin Emulsion with a dressing of choice.
Description OTC Product:
Sinclair Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation and wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050158 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050158: Sinclair Seborrhea Emulsion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050158
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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