# K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Anacapa Technologies, Inc.
- Decided: Apr 23, 2008 after 127 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: 5 generations back to K914579 (1992). 25 ancestors in all.
66 later devices descend from it; 17 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062212: Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S, Anacapa Technologies, Inc. (2006) Summary page 1.
- K042729: Dermacyn Wound Irrigation, Oculus Innovative Sciences, Inc. (2005) Summary page 3.
- K063069: Silvaklenz Skin and Wound Clenser Solution, Medical Molecular Therapuetics, LLC (2007) Summary page 3.

## Most influential descendants
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser (2009), 37 descendants of its own
- 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
- K101882: Prontosan Antimicrobial Wound Gel (2010), 21 descendants of its own
- K093697: Vashe Wound Therapy Solution (2010), 20 descendants of its own

## Indications for use
OTC: AnaseptTM Antimicrobial Skin and Wound Cleanser is intended for OTC use for mechanical cleansing of dirt and debris form skin abrasions, minor irritations, cuts, exit sites and intact skin. Professional Use: AnaseptTM Antimicrobial Skin and Wound Cleanser is intended for professional use for cleansing and removal of foreign material including micro-organisms and debris from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree bums, grafted and donor sites. OTC: AnaseptTM Antimicrobial Skin and Wound Gel is intended for OTC use for management of Skin Abrasions and lacerations, minor irritations, cuts, exit sites and intact skin. Professional Use: Anaseptrm Antimicrobial Skin and Wound Gel is intended to be used by health care professionals for the maniagement of wounds such as Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites.

Source page: https://510kreport.com/device/K073547
Methodology: https://510kreport.com/methodology