# Celleration, Inc.

- Location (FDA's records): Eden Prairie, MN
- FDA decisions: 4 (2004–2014): 3 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Celleration, Inc. (3); Celleration (1)
- Product codes: NRB (4)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kinetic Concepts, Inc.: 1 (https://510kreport.com/company/kinetic-concepts)
- Neogen Technologies, Inc.: 1 (https://510kreport.com/company/neogen-technologies)
- Blue Sky Medical Group Incorporated: 1 (https://510kreport.com/company/blue-sky-medical-group)

## Firms that cite its devices most
- Arobella Medical, LLC: 3 (https://510kreport.com/company/arobella-medical)
- Alliqua Biomedical, Inc.: 1 (https://510kreport.com/company/alliqua-biomedical)

## Its most-cited devices
- K050129: Celleration Mist Therapy System 5.1 (2005), cited by 2
- DEN040004: Celleration Mist Therapy System (2004), cited by 1
- K140782: Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator (2014), cited by 1
- K122246: Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12 (2012), cited by 1

## Recent decisions
- K140782: Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator (Aug 13, 2014)
- K122246: Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12 (Aug 13, 2012)
- K050129: Celleration Mist Therapy System 5.1 (May 17, 2005)
- DEN040004: Celleration Mist Therapy System (Jun 25, 2004)

Source page: https://510kreport.com/company/celleration