# K020969: Vacurect Vacuum Constriction Device

- Pathway: 510(k) (Traditional)
- Applicant: Vacurect Manufacturing (Pty), Ltd.
- Decided: Jun 5, 2002 after 71 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: 3 generations back to K841257 (1984). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981506: Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum Erection Dev), Repro-Med Systems, Inc. (1998) Summary page 1.
- K980291: Impower External Vacuum System, Imagyn Medical Technologies, Inc. (1998) Summary page 1.

## Indications for use
The Vacurect vacuum component is intended to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis. The constriction ring is intended to maintain penile rigidity in men with erectile dysfunction. The Vacurect Vacuum Constriction Device is intended for over-the-counter use.

Source page: https://510kreport.com/device/K020969
Methodology: https://510kreport.com/methodology