# K990509: Oligon Foley Catheter (16 FR) #33816/Oligon Foley Catheter (18 FR) #33818

- Pathway: 510(k) (Abbreviated)
- Applicant: Implemed, Inc.
- Decided: May 18, 1999 after 89 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 K933400 (1993). 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)
- K933400: Kendall Curity 100% Silicone Foley Catheter W/Temperature Sensor, Kendall Healthcare Products Co. Div.Of Tyco Health (1993) Summary page 1.

## Indications for use
The OLIGON™ FOLEY CATHETER is used to pass fluids to or from the urinary tract.

Source page: https://510kreport.com/device/K990509
Methodology: https://510kreport.com/methodology