# K022670: Carraklenz and Ultraklenz

- Pathway: 510(k) (Traditional)
- Applicant: Carrington Laboratories, Inc.
- Decided: Oct 17, 2002 after 66 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: 2 generations back to K945802 (1995). 3 ancestors in all.
105 later devices descend from it; 9 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)
- K965120: Allclenz Wound Cleanser, Dpt Laboratories, Ltd. (1997) Summary page 2.
- K954743: Dermagran Wound Dressing Cleaner W/Zinc, Derma Sciences, Inc. (1995). Our reading of the summary gave K354743, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Derma Sciences Dermagran Wound Cleanser with Zinc”.
- K945802: Dermagran Wound Cleanser with Zinc, Derma Sciences, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser (2009), 37 descendants of its own

## Indications for use
The Carrington Wound Cleansers are surfactant wound cleansers intended for the removal of foreign material such as dirt and debris from dermal wounds. CarraKlenz is a wound cleanser that is indicated for high, medium, and low exudating wounds. UltraKlenz is a gentle wound cleanser which is used on intact skin.

Source page: https://510kreport.com/device/K022670
Methodology: https://510kreport.com/methodology