# DEN040004: Celleration Mist Therapy System

- Pathway: De Novo (Post-NSE)
- Applicant: Celleration
- Decided: Jun 25, 2004 after 57 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K050129: Celleration Mist Therapy System 5.1 (2005), 6 descendants of its own
- K062544: AR1000 Ultrasonic Wound Therapy System (2007), 5 descendants of its own
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories (2011), 2 descendants of its own
- K072904: Sonoca 180/195 Wound Care System (2008), 1 descendant of its own
- K131096: AR1000 Series Ultrasonic Wound Therapy System (2014), 0 descendants of its own

Source page: https://510kreport.com/device/DEN040004
Methodology: https://510kreport.com/methodology