# K082074: Atricure CRYO1 Cryo-Ablation Probe

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Mar 2, 2009 after 222 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942299 (1995). 44 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 61 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.
- K970496: Heartport Maze System: Cryoprobe Set, Heartport, Inc. (1997) Summary page 1.
- K053436: Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console, Cryocath Technologies, Inc. (2006) Summary page 1.

## Most influential descendants
- K111042: Atricure Cryo Module (2011), 14 descendants of its own
- 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

## Recalls of this device
- Nov 21, 2014 · Class II · Z-0895-2015: Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile bar

## Indications for use
The Cryol cryo-ablation probe is a sterile, single use device intended for use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.

Source page: https://510kreport.com/device/K082074
Methodology: https://510kreport.com/methodology