# K971257: Vtu-1 Vacuum Erection System

- Pathway: 510(k) (Traditional)
- Applicant: Mckenna & Cuneo
- Decided: Oct 3, 1997 after 182 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K974470: Vtu-E Vacuum Erection System (1998), 0 descendants of its own

## Indications for use
The VTU-1 is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.

Source page: https://510kreport.com/device/K971257
Methodology: https://510kreport.com/methodology