# K121507: Atricure Cryo Module System (Acm, CRYO1, and Cryoice)

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Jun 6, 2012 after 16 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: 11 generations back to K942299 (1995). 47 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112072: Atricure Cryo Module System, AtriCure, Inc. (2011) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The Atriure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the Atriure Cryo Module (ACM)-a non-sterile, reusable device-used with the Cryol cryo-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/K121507
Methodology: https://510kreport.com/methodology