# K203661: CRYO Arctic, CRYO Penguin

- Pathway: 510(k) (Traditional)
- Applicant: Cryoscience North America, Inc.
- Decided: May 25, 2022 after 526 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: 6 generations back to K991514 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030281: Cryotron 2 Cryotherapy Device, Cryonic Medical North America (2003) Summary page 5.
- K193665: Frozen N, Yozma Bmtech Co., Ltd. (2020) Summary page 5.

## Indications for use
The CRYO Penguin is indicated 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/K203661
Methodology: https://510kreport.com/methodology