# K050129: Celleration Mist Therapy System 5.1

- Pathway: 510(k) (Traditional)
- Applicant: Celleration, Inc.
- Decided: May 17, 2005 after 118 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
Longest line of descent: 3 generations back to K945062 (1995). 8 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN040004: Celleration Mist Therapy System, Celleration (2004). Our OCR of the scanned summary read K032378, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040004, Celleration Mist Therapy System (Celleration), granted Jun 25, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K032310: Mini V.a.C., V.a.C. Freedom, V.a.C. Ats, Kinetic Concepts, Inc. (2003) Summary page 1.
- K032301: Neogen One, Closed Wound Drain System, Part Number: NG9900, Neogen Technologies, Inc. (2003) Summary page 1.
- K042134: Versatile 1 Wound Vacuum System, Blue Sky Medical Group Incorporated (2004) Summary page 1.

## Most influential descendants
- 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
- K123980: Sonicone Plus Ultrasound Wound Care System and Accessories (2013), 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/K050129
Methodology: https://510kreport.com/methodology