510(k) · Cleared

Cleared

Epi-Max

K041059510(k) TraditionalCleared May 17, 2005389-day reviewClass U

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

Dermagenics, Inc. · FRO Dressing, Wound, Drug

Cleared on May 17, 2005 after a 389-day review. The summary cites 3 numbers, none of which could be confirmed as its predicate (see the table below). 1 later device descends from it.

Decided: May 17, 2005
Review: 389 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 3

1 later device descends from it, 1 citing it directly.

This deviceK041059 Epi-MaxDermagenics, Inc. · 2005
Descendant · cites it directly · 0 of its ownK110457 3M Tegaderm Matrix Dressing3M Company · 2011

Most influential descendants

Showing 1 of 1 · See all

K1104573M Tegaderm Matrix Dressing3M Company · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K041059	Epi-Max	Dermagenics, Inc.	2005	—
+1	K110457	3M Tegaderm Matrix Dressing	3M Company	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K041059, 2005–2011Source: 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? (3)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K973507	FDA’s K973507 is Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Kendall Healthcare Products Co. Div.Of Tyco Health	1997	—
Kept off the family tree	K942459	FDA’s K942459 is Curasalt Hypertonic Saline Dressing Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Kendall Healthcare Products Co. Div.Of Tyco Health	1994	—
Kept off the family tree	K944468	FDA’s K944468 is Kerlix Zinc Saline Dressing Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Kendall Healthcare Products Co. Div.Of Tyco Health	1994	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K110457	3M Tegaderm Matrix Dressing	3M Company	2011	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?

Of its descendants, K110457 (3M Company, 2011) has gone furthest, with 0 descendants of its own.

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?

For use as a wound dressing to manage pressure ulcers

(stages I-IV), stasis ulcers, diabetic skin ulcers, skin

irritations, cuts, and abrasions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041059 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041059: Epi-Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041059

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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