# K981506: Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum Erection Dev)

- Pathway: 510(k) (Traditional)
- Applicant: Repro-Med Systems, Inc.
- Decided: Jun 25, 1998 after 59 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: 2 generations back to K841257 (1984). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 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 2.
- K974173: Erecaid System/Stay Erec System, Imagyn Medical Technologies, Inc. (1998) Summary page 2.
- K904485: Support Ring, Numedtec, Inc. (1990) Summary page 2.

## 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
The RESTORE Vacuum Erection Device consists of two main parts: the vacuum pump and constriction ring. Intended use statements for these are as follows. Vacuum Pump (intended use) - used to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood into the penile corpora cavernosa causing the penis to become erect and rigid. Constriction Ring (intended use) - used to maintain penile rigidity in men with er erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump.

Source page: https://510kreport.com/device/K981506
Methodology: https://510kreport.com/methodology