# K142592: CleanSmart Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Simple Science, LLC
- Decided: Sep 2, 2015 after 352 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: 10 generations back to K914579 (1992). 44 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113693: Nixall TM Wound and Skin Care, Seriously Clean, Ltd. (2012) Summary page 4.
- K133542: Puracyn Plus Skin and Wound, Innovacyn, Inc. (2014) Summary page 4.
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser, Oculus Innovative Sciences, Inc. (2009) Summary page 4.
- K093697: Vashe Wound Therapy Solution, Puricore, Inc. (2010) Summary page 4.

## Most influential descendants
- K160095: Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz (2016), 3 descendants of its own
- K181074: Simple Science Antimicrobial Facial and Eyelid Cleanser (2018), 2 descendants of its own
- K233399: Microdacyn Wound Care Solution (2024), 1 descendant of its own
- K261023: Microdacyn Wound Irrigation Solution (2026), 0 descendants of its own

## Indications for use
For management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, minor burns and intact skin. For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first-and second-degree burns, grafted and donor sites, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

Source page: https://510kreport.com/device/K142592
Methodology: https://510kreport.com/methodology