# K111313: Exsept Skin and Wound Cleanser with Antimicrobial Preservative

- Pathway: 510(k) (Traditional)
- Applicant: Alcavis Hdc, LLC
- Decided: Dec 14, 2011 after 218 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K914579 (1992). 28 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061467: Exsept WC Wound Cleanser, Alcavis International, Inc. (2007) Summary page 1.
- K063069: Silvaklenz Skin and Wound Clenser Solution, Medical Molecular Therapuetics, LLC (2007) Summary page 1.
- K042729: Dermacyn Wound Irrigation, Oculus Innovative Sciences, Inc. (2005) Summary page 1.
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc. (2008) Summary page 1.
- K090791: Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5%, Century Pharmaceuticals, Inc. (2009) Summary page 1.

## Most influential descendants
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) (2014), 8 descendants of its own
- K141012: Hydrocleanse Wound Care Solution (2014), 4 descendants of its own
- K161034: Microcyn Plus Wound Care Solution (2016), 3 descendants of its own
- K243415: Granudacyn® Wound Irrigation Solution (2025), 1 descendant of its own
- K213514: Spectricept Skin and Wound Cleanser (2023), 1 descendant of its own

## Indications for use
OTC: ExSept Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor skin and nail irritations, minor cuts, and intact skin. Professional Use: Under supervision of healthcare professionals, ExSept Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, ingrown toe nails, post surgical wounds, first and second degree burns, grafted and donor sites, and exit sites.

Source page: https://510kreport.com/device/K111313
Methodology: https://510kreport.com/methodology