510(k) · Cleared
ClearedDermiseb Cream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Igi Laboratories, Inc. · FRO Dressing, Wound, Drug
Cleared on Aug 28, 2013 as substantially equivalent to K050158 (Sinclair Pharmaceuticals, Ltd., 2006) after a 267-day review. Its family tree reaches back 3 generations to 1996. 4 later devices descend from it.
- Decided
- Aug 28, 2013
- Review
- 267 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961758 (1996). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
- 2 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
- 1 generation backK050158 Sinclair Seborrhea EmulsionSinclair Pharmaceuticals, Ltd. · 2006
- This deviceK123724 Dermiseb CreamIgi Laboratories, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK152945 Alevicyn SG Antipruritic GelOculus Innovative Sciences · 2015
- Descendant · 2 generations on · 1 of its ownK171935 Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK173896 Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK162217 LOYONOculus Innovative Sciences · 2017
Most influential descendants
Showing 4 of 4 · See all- K152945Alevicyn SG Antipruritic GelOculus Innovative Sciences · 2015 · cites it directly3descendants
- K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc. · 2017 · 2 generations on1descendant
- K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc. · 2018 · 3 generations on0descendants
- K162217LOYONOculus Innovative Sciences · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961758 | Carasyn Hydrogel Wound Products | Carrington Laboratories, Inc. | 1996 | — |
| −2 | K024367 | Sinclair Wound and Skin Emulsion | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −1 | K050158 | Sinclair Seborrhea Emulsion | Sinclair Pharmaceuticals, Ltd. | 2006 | — |
| 0 (this device) | K123724 | Dermiseb Cream | Igi Laboratories, Inc. | 2013 | — |
| +1 | K152945 | Alevicyn SG Antipruritic Gel | Oculus Innovative Sciences | 2015 | — |
| +2 | K171935 | Alevicyn SG Antimicrobial Gel | Sonoma Pharmaceuticals, Inc. | 2017 | — |
| +3 | K173896 | Microcyn Antimicrobial Hydrogel | Sonoma Pharmaceuticals, Inc. | 2018 | — |
| +2 | K162217 | LOYON | Oculus Innovative Sciences | 2017 | — |
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 |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K050158 | Sinclair Seborrhea EmulsionSummary page 1…Dressing, Wound & Burn, Hydrogel w/drug and/or biologic Predicate Device Promiseb~i Topical Cream; marketed by Promius PharmaLLC 510(k) K(050158 Description Non-steril , off-white to slight pale-yellow colored, low odor, steroid-free,… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152945 | Alevicyn SG Antipruritic Gel | 2015 | 3 |
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 17 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K152945 (Oculus Innovative Sciences, 2015) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K050158.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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, Dermiseb Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Dermiseb Cream also aids to relieve dry, waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.
Dermiseb Cream is indicated for use in:
* Seborrhea
* Seborrheic Dermatitis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123724 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123724: Dermiseb Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123724
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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