# K122246: Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12

- Pathway: 510(k) (Special)
- Applicant: Celleration, Inc.
- Decided: Aug 13, 2012 after 17 days
- Product code: NRB (Wound Cleaner, Ultrasound)
- Device class: 2
- Regulation: 21 CFR 878.4410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K131096: AR1000 Series Ultrasonic Wound Therapy System (2014), 0 descendants of its own

## Indications for use
The MIST Therapy System produces a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.

Source page: https://510kreport.com/device/K122246
Methodology: https://510kreport.com/methodology