# K181616: PSM 3-Way Silicone Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pathway, LLC
- Decided: Sep 21, 2018 after 94 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: 4 generations back to K896053 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091767: 3 Way Silicone Foley Balloon Catheter, Cook Urological, Inc. (2009) Summary page 4.

## Indications for use
Urological catheter intended for drainage/irrigation of the urinary tract. Catheterization is accomplished through the urinary tract, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.

Source page: https://510kreport.com/device/K181616
Methodology: https://510kreport.com/methodology