510(k) · Cleared

Cleared

The Performance Plus Confidence Rings, the Performance Plus Erection Inducer Device

K974082510(k) TraditionalCleared Feb 27, 1998121-day reviewClass II21 CFR 876.5020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Performance Plus, Inc. · LKY Device, External Penile Rigidity

Cleared on Feb 27, 1998 as substantially equivalent to K891125 (Performance, Inc., 1989) and 1 other predicate after a 121-day review. Its family tree reaches back 1 generation to 1989.

Decided: Feb 27, 1998
Review: 121 days
Class: Class II
Product code: LKY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K891125 (1989). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK891125 Constrictor Ring for Penile ErectionPerformance, Inc. · 1989
This deviceK974082 The Performance Plus Confidence Rings, the Performance Plus Erection…Performance Plus, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K891125	Constrictor Ring for Penile Erection	Performance, Inc.	1989	—
0 (this device)	K974082	The Performance Plus Confidence Rings, the Performance Plus Erection Inducer…	Performance Plus, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0

FIG. 1 — Lineage of K974082, 1989–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LKY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K891125	Constrictor Ring for Penile Erection Summary page 2 …lus Inc. 510(k) Notification: OTC Labeling Confidence Rings/Erection Inducer Device Attachment 1 Comparative Information: These devices are identical to the predicates, K891125(Confidence Rings) and K896060 (E.I.D) in materials,dimensions, performance, and intended use. The labeling is changed to provide…	Performance, Inc.	1989	—
*	K896060	Erection Inducer Device (Eid) Summary page 2 …OTC Labeling Confidence Rings/Erection Inducer Device Attachment 1 Comparative Information: These devices are identical to the predicates, K891125(Confidence Rings) and K896060 (E.I.D) in materials,dimensions, performance, and intended use. The labeling is changed to provide the information needed for saf…	Performance Medical, Inc.	1990	—

Also cleared against K891125: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
3 other devices also cite its predicate K891125.

How does its category compare?

All LKY devices

LKY Device, External Penile Rigidity: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LKY

FDA has decided no LKY device since 2007.

Median 510(k) review, days · LKY

Too few LKY 510(k)s in any year since 2007 to give a median.

Recalls per year · LKY

No recall names LKY since 2007.

Adverse event reports per year · LKY

2in 2023

2007high 3 (2018) · low 0 (2007)2025

MAUDE reports naming product code LKY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	1
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	1
2014	—	1
2015	—	0
2016	—	1
2017	—	2
2018	—	3
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	2
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

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…

Read the full statement (116 words)

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974082 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974082: The Performance Plus Confidence Rings, the Performance Plus Erection Inducer Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974082

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026