# K182392: Frozen C

- Pathway: 510(k) (Traditional)
- Applicant: B.M. Tech. Worldwide Co., Ltd.
- Decided: Oct 30, 2018 after 56 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: 4 generations back to K991514 (1999). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170810: Cryofos, Cryofos Medical GmbH (2017) Summary page 4.

## Most influential descendants
- K201260: Dermal Cooling System (2020), 3 descendants of its own
- K203006: R2 Dermabrasion Tip (for Dermal Cooling System) (2021), 2 descendants of its own
- K213294: Dermal Cooling System (2022), 1 descendant of its own
- K193665: Frozen N (2020), 1 descendant of its own
- K253261: Apollo Quattro (APQ-10M) (2026), 0 descendants of its own

## Indications for use
The FROZEN C, hyperbaric CO2 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/K182392
Methodology: https://510kreport.com/methodology