# K252023: MiraChlor Antimicrobial Wound Solution

- Pathway: 510(k) (Traditional)
- Applicant: Letus Corporation
- Decided: Mar 25, 2026 after 268 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: 9 generations back to K914579 (1992). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123072: Vashe Wound Therapy Solution, Puricore, Inc. (2013) Summary page 5.

## Indications for use
Under the supervision of a healthcare professional, MiraChlorTM Wound Cleanser Solutions is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, partial-thickness wounds, first- and superficial second-degree burns, abrasions of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds. MiraChlorTM Wound Cleanser Solutions is intended for OTC use in the management of minor skin abrasions, minor lacerations, minor cuts, and intact skin.

Source page: https://510kreport.com/device/K252023
Methodology: https://510kreport.com/methodology