# K193665: Frozen N

- Pathway: 510(k) (Traditional)
- Applicant: Yozma Bmtech Co., Ltd.
- Decided: May 28, 2020 after 149 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K991514 (1999). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182392: Frozen C, B.M. Tech. Worldwide Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K203661: CRYO Arctic, CRYO Penguin (2022), 0 descendants of its own

## Indications for use
The FROZEN N, cryotherapy device using liquid nitrogen vapor, 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/K193665
Methodology: https://510kreport.com/methodology