# K142203: Atricure Cryo Module System; cryoICE cryoablation probe

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Nov 25, 2014 after 106 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: 13 generations back to K942299 (1995). 53 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082074: Atricure CRYO1 Cryo-Ablation Probe, AtriCure, Inc. (2009) Summary page 4.
- K111042: Atricure Cryo Module, AtriCure, Inc. (2011) Summary page 4.
- K112072: Atricure Cryo Module System, AtriCure, Inc. (2011) Summary page 4.
- K121507: Atricure Cryo Module System (Acm, CRYO1, and Cryoice), AtriCure, Inc. (2012) Summary page 4.
- K140058: Atricure Cryo Module System, AtriCure, Inc. (2014) Summary page 4.
- K031482: Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe, C) Cryostar 2MM Cryoprobe, D) Convenience, Cryomedical Instruemts, Ltd. (2003) Summary page 4.

## Most influential descendants
- K180138: AtriCure cryoICE cryo-ablation probe (CRYO2) (2018), 4 descendants of its own
- K182565: AtriCure cryoICE cryoSPHERE cryoablation probe (2018), 3 descendants of its own
- K200697: AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) (2020), 2 descendants of its own
- K152337: cryoFORM cryoICE cryoablation probe (2016), 2 descendants of its own
- K251928: CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) (2026), 0 descendants of its own

## Indications for use
The AtriCure Cryo Module is a non-sterile, reusable device which delivers cryogenic energy, namely nitrous oxide, to AtriCure’s cryo-ablation probes. AtriCure’s cryoICE™ cryo-ablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.

Source page: https://510kreport.com/device/K142203
Methodology: https://510kreport.com/methodology