# K111042: Atricure Cryo Module

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: May 26, 2011 after 41 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: 9 generations back to K942299 (1995). 45 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811390: CCS100 Cryosurgical System, Frigitronics of Connecticut, Inc. (1981) Summary page 1.
- K082074: Atricure CRYO1 Cryo-Ablation Probe, AtriCure, Inc. (2009) Summary page 1.

## Most influential descendants
- K112072: Atricure Cryo Module System (2011), 13 descendants of its own
- K121507: Atricure Cryo Module System (Acm, CRYO1, and Cryoice) (2012), 11 descendants of its own
- K140058: Atricure Cryo Module System (2014), 10 descendants of its own
- K142203: Atricure Cryo Module System; cryoICE cryoablation probe (2014), 9 descendants of its own
- K180138: AtriCure cryoICE cryo-ablation probe (CRYO2) (2018), 4 descendants of its own

## Indications for use
The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a non-sterile, reusable device-used with the Cryol cryc-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.

Source page: https://510kreport.com/device/K111042
Methodology: https://510kreport.com/methodology