# K063069: Silvaklenz Skin and Wound Clenser Solution

- Pathway: 510(k) (Traditional)
- Applicant: Medical Molecular Therapuetics, LLC
- Decided: Jul 13, 2007 after 280 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: 4 generations back to K914579 (1992). 23 ancestors in all.
73 later devices descend from it; 6 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042729: Dermacyn Wound Irrigation, Oculus Innovative Sciences, Inc. (2005) Summary page 1.
- K022670: Carraklenz and Ultraklenz, Carrington Laboratories, Inc. (2002) Summary page 1.
- K040019: Silverseal, Noble Fiber Technologies (2004) Summary page 1.
- K011994: Acryderm Silver Anttimicrobial Wound Gel Model# a-002101, Acrymed, Inc. (2001) Summary page 1.
- K023612: Silverlon Contact Wound Dressing, Argentum International, LLC (2003) Summary page 1.

## Most influential descendants
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), 66 descendants of its own
- 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

## Indications for use
For normal skin and minor wounds, ulcerations and bums, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing action. To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree bums, cuts, abrasions and minor skin irritations.

Source page: https://510kreport.com/device/K063069
Methodology: https://510kreport.com/methodology