# K942299: Endocare Cryotherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Cytocare, Inc.
- Decided: Jan 19, 1995 after 252 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
No predicates in its family tree.
116 later devices descend from it; 2 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963826: Endocare Crycare Cryosurgical System (1996), 115 descendants of its own
- K973686: Endocare Cryocare Cryosurgical System (1997), 94 descendants of its own
- K980110: Endocre Cryocare Cryosurgical System (1998), 93 descendants of its own
- K011722: Atricure Bipolar Coagulation System (2001), 92 descendants of its own
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 (2002), 90 descendants of its own

Source page: https://510kreport.com/device/K942299
Methodology: https://510kreport.com/methodology