# K965120: Allclenz Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Dpt Laboratories, Ltd.
- Decided: Mar 21, 1997 after 88 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945802 (1995). 1 ancestor in all.
107 later devices descend from it; 8 cite it directly.
1 of 109 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945802: Dermagran Wound Cleanser with Zinc, Derma Sciences, Inc. (1995) Summary page 1.

## Most influential descendants
- K022670: Carraklenz and Ultraklenz (2002), 105 descendants of its own
- K042729: Dermacyn Wound Irrigation (2005), 89 descendants of its own
- K063069: Silvaklenz Skin and Wound Clenser Solution (2007), 73 descendants of its own
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), 66 descendants of its own
- K060113: Dermacyn Wound Care (2006), 52 descendants of its own

## Indications for use
For the cleansing of dermal lesions such as stage I-V pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritation of the skin.

Source page: https://510kreport.com/device/K965120
Methodology: https://510kreport.com/methodology