# K974215: Vet-CO Otc Vacuum Device/Vet-CO Constriction Ring Set

- Pathway: 510(k) (Traditional)
- Applicant: Vetco, Inc.
- Decided: Feb 19, 1998 after 101 days
- Product code: LKY (Device, External Penile Rigidity)
- Device class: 2
- Regulation: 21 CFR 876.5020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The intended use of the device is to assist men who have difficulty in achieving an erection by using the vacuum device and maintaining a satisfactory erection by using the constriction rings. For men who are able to achieve an erection but not maintain it, the application of a constriction ring at the base of the penis can sufficiently reduce venous leak to maintain the erection. In this instance, they may not be required to use the vacuum device.

Source page: https://510kreport.com/device/K974215
Methodology: https://510kreport.com/methodology