# K243157: AtriCure cryoICE BOX (ACM)

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Oct 29, 2024 after 29 days
- Product code: GXH (Device, Surgical, Cryogenic)
- Device class: 2
- Regulation: 21 CFR 882.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K942299 (1995). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142203: Atricure Cryo Module System; cryoICE cryoablation probe, AtriCure, Inc. (2014) Summary page 5.

## Indications for use
The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure’s cryo-ablation PROBES.

Source page: https://510kreport.com/device/K243157
Methodology: https://510kreport.com/methodology