# K041983: Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016

- Pathway: 510(k) (Traditional)
- Applicant: Opticon Medical
- Decided: Nov 17, 2004 after 117 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K760093 (1976). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023090: Option-VF Urinary Catheter, FV14218, Opticon Medical, Inc. (2003) Summary page 1.
- K033830: Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage Adaptor, Model CDA1000, Opticon Medical, Inc. (2004) Summary page 1.
- K760093: Catheter, Silicone Foley (Bardex), C.R. Bard, Inc. (1976) Summary page 1.

## Most influential descendants
- K062240: Carevent (2006), 0 descendants of its own

## Recalls of this device
- Jul 11, 2016 · Class II · Z-2831-2016: During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.

## Indications for use
The OPTION-vm is indicated for use only for urinary bladder drainage in male patients: 1) who have acute conditions that require short-term (14 days or less) urinary management; 2) who are capable of operating the device in accordance with its instructions for use; and 3) for whom normal bladder cycling is not contraindicated.

Source page: https://510kreport.com/device/K041983
Methodology: https://510kreport.com/methodology