# K982970: Mri's All Silicone Irrigation 3-Way Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mri Manufacturing and Research, Inc.
- Decided: Oct 28, 1998 after 64 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 K800307 (1980). 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)
- K800307: Irrigation (3-Way) Foley Catheter, Abco Dealers, Inc. (1980)

## Indications for use
This urological catheter is intended for the infusion of Sterile solution into the bladder to irrigate, cleanse, or drain the contents of the bladder during surgical procedures.

Source page: https://510kreport.com/device/K982970
Methodology: https://510kreport.com/methodology