# K113693: Nixall TM Wound and Skin Care

- Pathway: 510(k) (Traditional)
- Applicant: Seriously Clean, Ltd.
- Decided: Dec 11, 2012 after 361 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: 7 generations back to K914579 (1992). 32 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser, Oculus Innovative Sciences, Inc. (2009) Summary page 1.
- K092232: Modification to:Vashe Wound Cleansing System, Model 9000-0014, Puricore, Inc. (2009) Summary page 2.
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- K133542: Puracyn Plus Skin and Wound (2014), 14 descendants of its own
- K181428: Clyra Wound Irrigation Solution (2019), 5 descendants of its own
- K202071: SURGIPHOR Wound Irrigation System (2020), 4 descendants of its own
- K142592: CleanSmart Wound Cleanser (2015), 4 descendants of its own
- K213616: BD Surgiphor Antimicrobial Irrigation System (2022), 3 descendants of its own

## Indications for use
Nixallm Wound and Skin Care, Is intended for over the counter and professional use as follows: OTC: Nixall"' Wound and Skin Care is for the management of, the irrigation of, the moistening of, and lubrication of minor skin abrasions, minor lacerations, minor burns, minor irritations, minor cuts, and intact skin. Prescription Use: Nixallm Wound and Skin Care is intended to be used by health care professionals in the management, via dlebridement of wounds such as stage I-V pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.

Source page: https://510kreport.com/device/K113693
Methodology: https://510kreport.com/methodology