# K172203: CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray

- Pathway: 510(k) (Traditional)
- Applicant: Nuance Medical, LLC
- Decided: Oct 18, 2017 after 89 days
- Product code: MLY (Vapocoolant Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991514 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021726: Gebauer's Instant Ice, Gebauer Co. (2002) Summary page 4.

## Indications for use
Mist Spray: CryoDose TA OTC is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries. Stream Spray: CryoDose TA OTC is used like ice for muscle spasm and for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.

Source page: https://510kreport.com/device/K172203
Methodology: https://510kreport.com/methodology