# K121878: Cardioblate Cryoflex Surgical Ablation Probes

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Nov 2, 2012 after 127 days
- Product code: OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K123733: Cardioblate Cryoflex Surgical Ablation System (2013), 1 descendant of its own
- K191526: Cardioblate CryoFlex Surgical Ablation System (2019), 0 descendants of its own

## Indications for use
The Cardioblate Cryolex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate Cryolex 7 cm, 10 cm, and 10-S probes plus the Clamp and Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Source page: https://510kreport.com/device/K121878
Methodology: https://510kreport.com/methodology