# K030281: Cryotron 2 Cryotherapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Cryonic Medical North America
- Decided: Aug 20, 2003 after 205 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.
14 later devices descend from it; 2 cite it directly.
0 of 17 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 1.

## Most influential descendants
- K170810: Cryofos (2017), 13 descendants of its own
- K182392: Frozen C (2018), 6 descendants of its own
- K203481: CryoVIVE (2021), 5 descendants of its own
- K220674: TargetCool (2022), 4 descendants of its own
- K221234: TargetCool (2022), 3 descendants of its own

## Indications for use
The CRYOTRON 2" Cryotherapy Device is for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

Source page: https://510kreport.com/device/K030281
Methodology: https://510kreport.com/methodology