# K961697: Opticon Female Urinary Incontinence Catheter for Continuous Drainage

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Intl., Inc.
- Decided: Aug 30, 1996 after 120 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 K760093 (1976). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760093: Catheter, Silicone Foley (Bardex), C.R. Bard, Inc. (1976) Summary page 1.
- K941692: Female Length All Silicone Urological Catheter, Rochester Medical Corp. (1995) Summary page 1.

## Most influential descendants
- K023090: Option-VF Urinary Catheter, FV14218 (2003), 3 descendants of its own
- K033830: Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage Adaptor, Model CDA1000 (2004), 2 descendants of its own
- K041983: Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016 (2004), 1 descendant of its own
- K062240: Carevent (2006), 0 descendants of its own
- K970716: Opticon Direct Male Urinary Catheter for Continuous  Drainage (1997), 0 descendants of its own

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

Source page: https://510kreport.com/device/K961697
Methodology: https://510kreport.com/methodology