510(k) · Cleared
Recalled · Class II · 2016Ceramax Skin Barrier Cream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Innovative Sciences · FRO Dressing, Wound, Drug
Cleared on Nov 23, 2015 as substantially equivalent to K052643 (Ceragenix Corporation, 2006) and 1 other predicate after a 122-day review. Its family tree reaches back 5 generations to 1996. It has been recalled once.
- Decided
- Nov 23, 2015
- Review
- 122 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K961758 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
- 4 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
- 3 generations backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
- 2 generations backK052643 EpiceramCeragenix Corporation · 2006
- 1 generation backK110757 TL-Cermide Skin Barrier EmulsionTrigen Laboratories, Inc. · 2011
- This deviceK152055 Ceramax Skin Barrier CreamOculus Innovative Sciences · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961758 | Carasyn Hydrogel Wound Products | Carrington Laboratories, Inc. | 1996 | — |
| −4 | K024367 | Sinclair Wound and Skin Emulsion | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −3 | K041342 | Impruv a.I. Cream Wound and Skin Emulsion | Stiefel Laboratories, Inc. | 2005 | — |
| −2 | K052643 | Epiceram | Ceragenix Corporation | 2006 | — |
| −1 | K110757 | TL-Cermide Skin Barrier Emulsion | Trigen Laboratories, Inc. | 2011 | — |
| 0 (this device) | K152055 | Ceramax Skin Barrier Cream | Oculus Innovative Sciences | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K052643 | EpiceramSummary page 4…Common Name: Wound Dressing Classification Name: Regulation: 21 CFR Unclassified, Pre-amendment status Product Code(s) FRO Device Panel TBD Legally marketed Epiceram K052643, and TL-Cermide K110757 device(s) to which equivalence is claimed: Reason for 510(k) New Device submission Device Description C… | 2006 |
| * | K110757 | TL-Cermide Skin Barrier EmulsionSummary page 4…ing Classification Name: Regulation: 21 CFR Unclassified, Pre-amendment status Product Code(s) FRO Device Panel TBD Legally marketed Epiceram K052643, and TL-Cermide K110757 device(s) to which equivalence is claimed: Reason for 510(k) New Device submission Device Description Ceramax emollient formula… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2016 | Class II | Z-0763-2017 | Packaging process control | Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- None of the 6 ancestors has a recall.
- 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. 2015, 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 health care professional, Ceramax is intended to be used as a topical skin care preparation to
relieve and to manage the burning, and itching associated with various dermatoses including atopic dermatitis, irritant
contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin
environment.
Ceramax may be used to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to
the healing process.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152055: Ceramax Skin Barrier Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152055
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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