# K172422: Kohli Urinary Drainage Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Nellie Medical, LLC
- Decided: Feb 9, 2018 after 183 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: 2 generations back to K040390 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063442: All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature Sensor, Degania Silicone, Ltd. (2007) Summary page 4.
- K142194: CytoSure Urinary Access System, Emmy Medical (2014) Summary page 4.

## Indications for use
The 2-Way Kohli urinary drainage catheter is intended for urological bladder drainage only with a maximum patient indwelling time of <30 days.

Source page: https://510kreport.com/device/K172422
Methodology: https://510kreport.com/methodology