510(k) · Cleared
ClearedTL-Cermide Skin Barrier Emulsion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trigen Laboratories, Inc. · FRO Dressing, Wound, Drug
Cleared on Aug 19, 2011 as substantially equivalent to K052643 (Ceragenix Corporation, 2006) after a 154-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Aug 19, 2011
- Review
- 154 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961758 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK110757 TL-Cermide Skin Barrier EmulsionTrigen Laboratories, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK152055 Ceramax Skin Barrier CreamOculus Innovative Sciences · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K152055Ceramax Skin Barrier CreamOculus Innovative Sciences · 2015 · cites it directly0descendants
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) | K110757 | TL-Cermide Skin Barrier Emulsion | Trigen Laboratories, Inc. | 2011 | — |
| +1 | K152055 | Ceramax Skin Barrier Cream | Oculus Innovative Sciences | 2015 | 1 |
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 |
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 |
|---|---|---|---|
| * | K052643 | EpiceramSummary page 1…substantially equivalent to the currently marketed device, EPICERAM® Skin Barrier Emulsion (Radiodermatitis Emulsion) cleared under K052643. K Itb07sl… | 2006 |
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 |
|---|---|---|---|
| K152055 | Ceramax Skin Barrier Cream | 2015 | 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 15 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K152055 (Oculus Innovative Sciences, 2015) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K052643.
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?
TL-Cermidle Skin Emulsion is 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. TL-Cermide Skin
Emulsion 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/K110757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110757: TL-Cermide Skin Barrier Emulsion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110757
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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