# K220674: TargetCool

- Pathway: 510(k) (Special)
- Applicant: Recensmedical, Inc.
- Decided: Mar 31, 2022 after 23 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). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203481: CryoVIVE, Recensmedical, Inc. (2021) Summary page 4.

## Most influential descendants
- K221234: TargetCool (2022), 3 descendants of its own
- K230599: TargetCool™ (2023), 2 descendants of its own
- K253114: TargetCool™ (RM-DT02W) (2025), 0 descendants of its own
- K253348: TargetCool-e (2025), 0 descendants of its own

## Indications for use
TargetCool™ 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/K220674
Methodology: https://510kreport.com/methodology