# K974470: Vtu-E Vacuum Erection System

- Pathway: 510(k) (Traditional)
- Applicant: Encore, Inc.
- Decided: Jan 9, 1998 after 44 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
Longest line of descent: 1 generation back to K971257 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971257: Vtu-1 Vacuum Erection System, Mckenna & Cuneo (1997) Summary page 1.

## Indications for use
The VTU-E is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.

Source page: https://510kreport.com/device/K974470
Methodology: https://510kreport.com/methodology