# K980948: Ved Valu- Vacuum Erection Device

- Pathway: 510(k) (Traditional)
- Applicant: Mission Pharmacal Comp
- Decided: Jun 25, 1998 after 104 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 VED VALU and VED VALU ULTRA vacuum erection devices consist of two main parts: the vacuum pump and constriction ring. Vacuum Pump — used to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood into the penile corpora cavernosa causing the penis to become erect and rigid. Constriction Ring — used to maintaln penile rigldity in me with eractile dysfunction by restricting pentle venous outflow after the patient has obtained an erection with the ald of a vacuum pump. VED VALU and VED VALU ULTRA are designed to help you create an erection sufficient to penetrate the vagina and have sexual intercourse. They are intented for use by men who have full or parlal Impotence. NOTE: Neither the VED VALU nor the VED VALU ULTRA is a contraceptive.

Source page: https://510kreport.com/device/K980948
Methodology: https://510kreport.com/methodology