# K203481: CryoVIVE

- Pathway: 510(k) (Traditional)
- Applicant: Recensmedical, Inc.
- Decided: May 13, 2021 after 167 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). 8 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K190407: CryoLab, Cryoconcepts LP (2019) Summary page 4.
- K170810: Cryofos, Cryofos Medical GmbH (2017) Summary page 5.
- K172769: CryOmega Flexx, Cryoconcepts LP (2017) Summary page 5.

## Most influential descendants
- K220674: TargetCool (2022), 4 descendants of its own
- 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
The CryoVIVE(Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures - Molluscum Contagiosum - Skin Tags - Actinic Keratosis - Lentigo - Verruca Plana - Verruca Vulgaris - Verruca Lesions - Genital Lesions - Seborrheic Keratosis The CryoVIVE(Cooling mode) 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/K203481
Methodology: https://510kreport.com/methodology