# K974173: Erecaid System/Stay Erec System

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Medical Technologies, Inc.
- Decided: Feb 25, 1998 after 112 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 K841257 (1984). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841257: Sta-Potent System, Nu-Potent (1984) Summary page 1.
- K912736: Erecaid (R) System Plus, Osbon Medical Systems, Ltd. (1991) Summary page 1.
- K901318: Stayerec System (TM), Osbon Medical Systems, Ltd. (1990) Summary page 1.

## Most influential descendants
- K981506: Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum Erection Dev) (1998), 2 descendants of its own
- 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
ErecAid® System-OTC and StayErec® System Tension Rings-OTC These devices are intended for the treatment or management of erectile dysfunction/impotence.

Source page: https://510kreport.com/device/K974173
Methodology: https://510kreport.com/methodology