# K160877: United Urologics Closed System Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Robling Medical, Inc.
- Decided: May 20, 2016 after 51 days
- Product code: KOD (Catheter, Urological)
- 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: 3 generations back to K973120 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032710: Closed System Intermittent Catheterization Kit, Apogee Medical, Inc. (2004) Summary page 4.

## Indications for use
United Urologics Closed System Intermittent Catheterization kit is intended to be used to drain urine from the patient's bladder into a collection bag.

Source page: https://510kreport.com/device/K160877
Methodology: https://510kreport.com/methodology