# K190060: Urethrotech UCD

- Pathway: 510(k) (Traditional)
- Applicant: Urethrotech
- Decided: Oct 4, 2019 after 266 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- 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 K980919 (1998). 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)
- K980919: All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton Catheter, Fortune Medical Instrument Corp. (1998) Summary page 4.

## Indications for use
The Urethrotech Urethral Catheterization Device is intended for use for bladder management including urine drainage, collection and measurement and / or bladder fluid instillation or irrigation.

Source page: https://510kreport.com/device/K190060
Methodology: https://510kreport.com/methodology