# K952895: CMS Urethral Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Cryomedical Sciences, Inc.
- Decided: Oct 24, 1995 after 123 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K963970: Endocare Cryocare Cryosurgical System Urethral Warming System (1997), 2 descendants of its own
- K211149: Urethral Warming Catheter Kit (2022), 0 descendants of its own
- K090978: UC-Care Warming System (2009), 0 descendants of its own
- K955011: Candela HCS 2000 Uretheral Warmer Catheter (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K952895
Methodology: https://510kreport.com/methodology