# K970716: Opticon Direct Male Urinary Catheter for Continuous  Drainage

- Pathway: 510(k) (Traditional)
- Applicant: Opticon Medical, Inc.
- Decided: May 16, 1997 after 78 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: 2 generations back to K760093 (1976). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961697: Opticon Female Urinary Incontinence Catheter for Continuous Drainage, Medical Device Intl., Inc. (1996) Summary page 1.

## Indications for use
The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage tube adaptors, tubes and bags.

Source page: https://510kreport.com/device/K970716
Methodology: https://510kreport.com/methodology