# K980919: All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Fortune Medical Instrument Corp.
- Decided: Mar 31, 1998 after 20 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132890: Suprapubic Catheter and Introducer Set (2014), 1 descendant of its own
- K131655: Lighthouse (TM) Urinary Catheter (2013), 1 descendant of its own
- K190060: Urethrotech UCD (2019), 0 descendants of its own
- K182066: O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (2018), 0 descendants of its own
- K140099: Lighthouse Urinary Catheter (2014), 0 descendants of its own

## Indications for use
The Silicone Foley Balloon Catheter and Nelation Catheter are intended for use as urinary catheters to pass fluids to and from the urinary bladder.

Source page: https://510kreport.com/device/K980919
Methodology: https://510kreport.com/methodology