# K190407: CryoLab

- Pathway: 510(k) (Traditional)
- Applicant: Cryoconcepts LP
- Decided: Apr 22, 2019 after 60 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
No predicates in its family tree.
6 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K203481: CryoVIVE (2021), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K190407
Methodology: https://510kreport.com/methodology