# K040779: Restore Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: May 17, 2004 after 52 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: 3 generations back to K945802 (1995). 4 ancestors in all.
28 later devices descend from it; 2 cite it directly.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022670: Carraklenz and Ultraklenz, Carrington Laboratories, Inc. (2002) Summary page 4.
- K965120: Allclenz Wound Cleanser, Dpt Laboratories, Ltd. (1997) Summary page 4.
- K945802: Dermagran Wound Cleanser with Zinc, Derma Sciences, Inc. (1995) Summary page 4.

## Most influential descendants
- K083355: Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 (2008), 13 descendants of its own
- K042084: Bioderm Sciences Wound Healing Spray (2005), 13 descendants of its own
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) (2014), 8 descendants of its own
- K083042: Wound Flush, Sterile Water & Normal Saline (2008), 7 descendants of its own
- K141012: Hydrocleanse Wound Care Solution (2014), 4 descendants of its own

## Indications for use
The restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.

Source page: https://510kreport.com/device/K040779
Methodology: https://510kreport.com/methodology