510(k) · Cleared

Cleared

Hydropermeate Topical Emulsion, ANSWER2SKIN Sunburn Relief Cream, ANSWER2SKIN First Aid Cream

K122595510(k) TraditionalCleared May 1, 2013250-day reviewClass U

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

Dermal Life, LLC · FRO Dressing, Wound, Drug

Cleared on May 1, 2013 as substantially equivalent to K964240 (Medix Pharmaceuticals Americas, Inc., 1997) after a 250-day review. Its family tree reaches back 1 generation to 1997.

Decided: May 1, 2013
Review: 250 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K964240 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK964240 Biafine Wound Dressing EmulsionMedix Pharmaceuticals Americas, Inc. · 1997
This deviceK122595 Hydropermeate Topical Emulsion, ANSWER2SKIN Sunburn Relief Cream…Dermal Life, LLC · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964240	Biafine Wound Dressing Emulsion	Medix Pharmaceuticals Americas, Inc.	1997	—
0 (this device)	K122595	Hydropermeate Topical Emulsion, ANSWER2SKIN Sunburn Relief Cream, ANSWER2SKIN…	Dermal Life, LLC	2013	—

FIG. 1 — Lineage of K122595, 1997–2013Source: 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? (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	Applicant	Decided	Recalls
*	K964240	Biafine Wound Dressing Emulsion Summary page 1 …ed Substantial Equivalence This 5 10(k) submission demonstrates that HYDROPERMEATE TM Topical Emulsion is substantially equivalent to SIAFINETM Wound Dressing Emulsion (K964240) in both technology and intended use. Device Description HYDROPERMEATE TM Topical Emulsion consists of approximately 75% purifie…	Medix Pharmaceuticals Americas, Inc.	1997	—

Also cleared against K964240: 12 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
12 other devices also cite its predicate K964240.

How does its category compare?

All FRO devices

FRO 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

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?

HYDROPERMEATETM Topical Emulsion is intended to be used as a wound dressing for the following indications:

* Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers

* Superficial wounds

* 1st and 2nd degree burns, including sunburns

* Dermal donor and graft site management

* Radiation dermatitis

* Minor abrasions

ANSWER2SKNTM SUNBURN RELIEF Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor burns, including minor sunburns.

ANSWER2SKINTM FIRST AID Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor superficial wounds and minor abrasions, including cuts and scrapes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122595 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122595: Hydropermeate Topical Emulsion, ANSWER2SKIN Sunburn Relief Cream, ANSWER2SKIN First Aid Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122595

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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