# K982275: Rapport V.T.D.

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford USA, Inc.
- Decided: Dec 4, 1998 after 158 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 K971443 (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)
- K971443: Rapport V.T.D., Owen Mumford USA, Inc. (1997) Summary page 2.

## Indications for use
Intended to achieve a penile erection for men suffering from erectile dysfunction

Source page: https://510kreport.com/device/K982275
Methodology: https://510kreport.com/methodology