# K041059: Epi-Max

- Pathway: 510(k) (Traditional)
- Applicant: Dermagenics, Inc.
- Decided: May 17, 2005 after 389 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 3 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K973507: Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317), Kendall Healthcare Products Co. Div.Of Tyco Health (1997). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K942459: Curasalt Hypertonic Saline Dressing, Kendall Healthcare Products Co. Div.Of Tyco Health (1994). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K944468: Kerlix Zinc Saline Dressing, Kendall Healthcare Products Co. Div.Of Tyco Health (1994). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K110457: 3M Tegaderm Matrix Dressing (2011), 0 descendants of its own

## Indications for use
For use as a wound dressing to manage pressure ulcers (stages I-IV), stasis ulcers, diabetic skin ulcers, skin irritations, cuts, and abrasions.

Source page: https://510kreport.com/device/K041059
Methodology: https://510kreport.com/methodology