# K143625: truFreeze System

- Pathway: 510(k) (Special)
- Applicant: CSA Medical, Inc.
- Decided: Jan 15, 2015 after 24 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: 9 generations back to K003811 (2001). 21 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133258: Trufreeze System, CSA Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K150920: truFreeze System (2015), 11 descendants of its own
- K152668: truFreeze System (2015), 10 descendants of its own
- K160273: truFreeze System (2016), 9 descendants of its own
- K161557: truFreeze System (2016), 8 descendants of its own
- K162695: truFreeze System (2016), 7 descendants of its own

## Recalls of this device
- Mar 25, 2015 · Class II · Z-1513-2015: TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax

## Indications for use
The truFreeze® System is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze® System is Indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

Source page: https://510kreport.com/device/K143625
Methodology: https://510kreport.com/methodology