# K140782: Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Celleration, Inc.
- Decided: Aug 13, 2014 after 135 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
- K162721: Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator (2016), 0 descendants of its own

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

Source page: https://510kreport.com/device/K140782
Methodology: https://510kreport.com/methodology