510(k) · Cleared

Cleared

Epiceram

K052643510(k) TraditionalCleared Apr 11, 2006197-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ceragenix Corporation · FRO Dressing, Wound, Drug

Cleared on Apr 11, 2006 as substantially equivalent to K024367 (Sinclair Pharmaceuticals, Ltd., 2003) and 3 other predicates after a 197-day review. Its family tree reaches back 3 generations to 1996. 16 later devices descend from it.

Decided: Apr 11, 2006
Review: 197 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K961758 (1996). 4 ancestors in all. 16 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 3 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
2 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
1 generation backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
This deviceK052643 EpiceramCeragenix Corporation · 2006
Descendant · cites it directly · 6 of its ownK093051 Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 2009
Descendant · 2 generations on · 4 of its ownK110727 Hylatopicplus CreamPrecision Dermatology Incorporated · 2011
Descendant · cites it directly · 1 of its ownK242406 SiOxC CreamSioxmed, LLC · 2025
Descendant · 2 generations on · 1 of its ownK113774 HPR Plus Emollient FoamPrugen IP Holdings, Inc. · 2012
Descendant · cites it directly · 1 of its ownK110757 TL-Cermide Skin Barrier EmulsionTrigen Laboratories, Inc. · 2011

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2008high 3 (2011) · low 0 (2010)2026

Most influential descendants

Showing 5 of 16 · See all

K093051Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 2009 · cites it directly6descendants
K110727Hylatopicplus CreamPrecision Dermatology Incorporated · 2011 · 2 generations on4descendants
K242406SiOxC CreamSioxmed, LLC · 2025 · cites it directly1descendant
K113774HPR Plus Emollient FoamPrugen IP Holdings, Inc. · 2012 · 2 generations on1descendant
K110757TL-Cermide Skin Barrier EmulsionTrigen Laboratories, Inc. · 2011 · cites it directly1descendant

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	K041342	Impruv a.I. Cream Wound and Skin Emulsion	Stiefel Laboratories, Inc.	2005	—
0 (this device)	K052643	Epiceram	Ceragenix Corporation	2006	—
+1	K093051	Hylatopic Plus Emollient Foam	Collegium Pharmaceutical Incorporated	2009	—
+2	K110727	Hylatopicplus Cream	Precision Dermatology Incorporated	2011	—
+1	K242406	SiOxC Cream	Sioxmed, LLC	2025	—
+2	K113774	HPR Plus Emollient Foam	Prugen IP Holdings, Inc.	2012	—
+1	K110757	TL-Cermide Skin Barrier Emulsion	Trigen Laboratories, Inc.	2011	—

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
2008	1	0
2009	1	0
2011	3	0
2012	3	0
2013	2	0
2015	1	0
2016	1	0
2017	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K052643, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K024367	Sinclair Wound and Skin Emulsion Summary page 1 …Biologic. Devices to Which New Device is Substantially Equivalent; * Sinclair Wound and Skin EmulsionTM - Sinclair Pharmaceuticals, Ltd (K024367, July 28, 2003); · Biafene Wound Dressing Emulsion (Radiodermatitis Emulsion) - Medix Pharmaceuticals Americas,…	Sinclair Pharmaceuticals, Ltd.	2003	—
*	K964240	Biafine Wound Dressing Emulsion Summary page 1 …ceuticals, Ltd (K024367, July 28, 2003); · Biafene Wound Dressing Emulsion (Radiodermatitis Emulsion) - Medix Pharmaceuticals Americas, Inc. (K964240, Jan. 22, 1997); * Carrasyn® Hydrogel Wound Dressing, which is also marketed under the name RadiaCare Gel J4ydr…	Medix Pharmaceuticals Americas, Inc.	1997	—
*	K961758	Carasyn Hydrogel Wound Products Summary page 1 …* Carrasyn® Hydrogel Wound Dressing, which is also marketed under the name RadiaCare Gel J4ydrogel Wound Dressing - Carrington Laboratories, Inc. (K961758, July 11, 1996); and · MimyxTM Cream - Steifel Laboratories, Inc. (K041342, July 19, 2005) 3. Device Description:…	Carrington Laboratories, Inc.	1996	—
*	K041342	Impruv a.I. Cream Wound and Skin Emulsion Summary page 1 …name RadiaCare Gel J4ydrogel Wound Dressing - Carrington Laboratories, Inc. (K961758, July 11, 1996); and · MimyxTM Cream - Steifel Laboratories, Inc. (K041342, July 19, 2005) 3. Device Description: EPICERAMrM is a non-sterile, viscous, lipid-rich emulsion presented for p…	Stiefel Laboratories, Inc.	2005	—

Also cleared against K024367: 9 other devices →

What descends from it? (16)

See all 16

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093051	Hylatopic Plus Emollient Foam	Collegium Pharmaceutical Incorporated	2009	6
K242406	SiOxC Cream	Sioxmed, LLC	2025	1
K110757	TL-Cermide Skin Barrier Emulsion	Trigen Laboratories, Inc.	2011	1
K252568	New Day Skin Spray	Silk Holdings, Inc.	2026	0
K171191	Hexagen Derm	Global Health Solutions, LLC	2017	0
K152055	Ceramax Skin Barrier Cream	Oculus Innovative Sciences	2015	0
K113807	Dexeryl Cream	Pierre Fabre Medical Devices	2012	0
K110732	Emulsion SB	Prugen IP Holdings, Inc.	2011	0
K080471	Radio Bioaquacare	Bioartificial Gel Technologies (Bagtech), Inc.	2008	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 10 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K093051 (Collegium Pharmaceutical Incorporated, 2009) has gone furthest, with 6 descendants of its own.
9 other devices also cite its predicate K024367.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRO

11in 2025

2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007high 297 (2015) · low 30 (2008)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?

EPICERAM® is a skin barrier 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, radiation dermatitis. EPICERAM® helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Apply Epiceram® in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin. If the skin is broken, cover Epiceram® with a dressing of choice.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052643 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052643: Epiceram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052643

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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