# K974082: The Performance Plus Confidence Rings, the Performance Plus Erection Inducer Device

- Pathway: 510(k) (Traditional)
- Applicant: Performance Plus, Inc.
- Decided: Feb 27, 1998 after 121 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 K891125 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891125: Constrictor Ring for Penile Erection, Performance, Inc. (1989) Summary page 2.
- K896060: Erection Inducer Device (Eid), Performance Medical, Inc. (1990) Summary page 2.

## Indications for use
Performance Plus Confidence Rings are devices that are placed around the base of the penis to help sustain an erection. An erection is achieved when the spongy corpora of the penis fills with arterial blood during sexual stimulation. In certain men, the penis may not become fully erect because the penile venous system drains too rapidly or leaks blood from the corpora. The rings operate by limiting venous return from the major superficial veins of the penis. The E.LD. system is an external erection device that induces penile rigidity though vacuum assisted vascular engorgement of the penis. Once erection is achieved, a Confidence ring is placed at the base of the penis to sustain the erection.

Source page: https://510kreport.com/device/K974082
Methodology: https://510kreport.com/methodology