# K060113: Dermacyn Wound Care

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences, Inc.
- Decided: Feb 22, 2006 after 36 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
Longest line of descent: 3 generations back to K945802 (1995). 4 ancestors in all.
52 later devices descend from it; 3 cite it directly.
1 of 57 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965120: Allclenz Wound Cleanser, Dpt Laboratories, Ltd. (1997) Summary page 1.
- K022670: Carraklenz and Ultraklenz, Carrington Laboratories, Inc. (2002) Summary page 1.

## Most influential descendants
- K072876: Prontosan Wound Irrigation Solution (2008), 29 descendants of its own
- K090141: Prontosan Antimicrobial Wound Gel (2009), 22 descendants of its own
- K101882: Prontosan Antimicrobial Wound Gel (2010), 21 descendants of its own
- K071056: Neutrophase Wound Cleanser (2007), 17 descendants of its own
- K081009: Neutrophase (2008), 16 descendants of its own

## Indications for use
Dermacyn™ is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.

Source page: https://510kreport.com/device/K060113
Methodology: https://510kreport.com/methodology