# K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences, Inc.
- Decided: Jun 2, 2009 after 125 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K914579 (1992). 26 ancestors in all.
37 later devices descend from it; 8 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- K100918: Vashe Wound Therapy System Model: 9000-0014 (2010), 31 descendants of its own
- K123072: Vashe Wound Therapy Solution (2013), 25 descendants of its own
- K093697: Vashe Wound Therapy Solution (2010), 20 descendants of its own
- K113693: Nixall TM Wound and Skin Care (2012), 15 descendants of its own
- K113820: Neutrophase Antimicrobial Wound Cleanser (2012), 15 descendants of its own

## Recalls of this device
- Nov 9, 2011 · Not classified · Z-0448-2012: Unapproved drug claims and those not approved under 510K clearance.
- Nov 9, 2011 · Not classified · Z-0449-2012: Unapproved drug claims and those not approved under 510K clearance.
- Nov 9, 2011 · Not classified · Z-0450-2012: Unapproved drug claims and those not approved under 510K clearance.

## Indications for use
Oculus Puracyn Skin and Wound Cleanser with Preservatives is intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin. Oculus Puracyn Skin and Wound Cleanser with Preservatives is intended to be used by health care professionals in the management, via debridement of wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.

Source page: https://510kreport.com/device/K090206
Methodology: https://510kreport.com/methodology