# K260919: Transurethral Catheter Safety Valve (TUCSV) (80050)

- Pathway: 510(k) (Traditional)
- Applicant: Class Medical, Ltd.
- Decided: Aug 5, 2026 after 139 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K182635 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182635: Signal Catheter, Safe Medical Design (2019) Summary page 5.

## Indications for use
The TUC Safety Valve is indicated for single use during inflation of a Foley catheter retaining balloon in adult patients. The TUCSV alerts the user of premature inflation of the balloon within the urethra and alleviates the pressure, to aid in the prevention of incorrect balloon placement.

Source page: https://510kreport.com/device/K260919
Methodology: https://510kreport.com/methodology