# K980291: Impower External Vacuum System

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Medical Technologies, Inc.
- Decided: Mar 11, 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 K920409 (1992). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920409: Dacomed Battery Operated Vacuum Erection Device, Dacomed Corp. (1992) Summary page 1.

## Most influential descendants
- K032776: Vacurect Vacuum Constriction Device (2003), 0 descendants of its own
- K020969: Vacurect Vacuum Constriction Device (2002), 0 descendants of its own

## Indications for use
This device is intended for the treatment or management of erectile dysfunction/impotence.

Source page: https://510kreport.com/device/K980291
Methodology: https://510kreport.com/methodology