# K090978: UC-Care Warming System

- Pathway: 510(k) (Traditional)
- Applicant: UC-CARE, Ltd.
- Decided: Aug 10, 2009 after 126 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: 6 generations back to K010991 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963970: Endocare Cryocare Cryosurgical System Urethral Warming System, Endocare, Inc. (1997) Summary page 2.
- K060390: Seednet, Seednet Gold, Cryohit, Cryo Thera, Galil Medical, Ltd. (2006) Summary page 2.

## Indications for use
The UC-CARE Warming System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate using cryosurgical systems that have been cleared for use on the prostate.

Source page: https://510kreport.com/device/K090978
Methodology: https://510kreport.com/methodology