510(k) · Cleared

Cleared

Erecaid System/Stay Erec System

K974173510(k) TraditionalCleared Feb 25, 1998112-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

Imagyn Medical Technologies, Inc. · LKY Device, External Penile Rigidity

Cleared on Feb 25, 1998 as substantially equivalent to K841257 (Nu-Potent, 1984) and 2 other predicates after a 112-day review. Its family tree reaches back 1 generation to 1984. 3 later devices descend from it.

Decided: Feb 25, 1998
Review: 112 days
Class: Class II
Product code: LKY
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K841257 (1984). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK841257 Sta-Potent SystemNu-Potent · 1984
This deviceK974173 Erecaid System/Stay Erec SystemImagyn Medical Technologies, Inc. · 1998
Descendant · cites it directly · 2 of its ownK981506 Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep…Repro-Med Systems, Inc. · 1998
Descendant · 2 generations on · 0 of its ownK032776 Vacurect Vacuum Constriction DeviceVacurect Manufacturing (Pty), Ltd. · 2003
Descendant · 2 generations on · 0 of its ownK020969 Vacurect Vacuum Constriction DeviceVacurect Manufacturing (Pty), Ltd. · 2002

Most influential descendants

Showing 3 of 3 · See all

K981506Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection…Repro-Med Systems, Inc. · 1998 · cites it directly2descendants
K032776Vacurect Vacuum Constriction DeviceVacurect Manufacturing (Pty), Ltd. · 2003 · 2 generations on0descendants
K020969Vacurect Vacuum Constriction DeviceVacurect Manufacturing (Pty), Ltd. · 2002 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K841257	Sta-Potent System	Nu-Potent	1984	—
0 (this device)	K974173	Erecaid System/Stay Erec System	Imagyn Medical Technologies, Inc.	1998	—
+1	K981506	Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile…	Repro-Med Systems, Inc.	1998	—
+2	K032776	Vacurect Vacuum Constriction Device	Vacurect Manufacturing (Pty), Ltd.	2003	—
+2	K020969	Vacurect Vacuum Constriction Device	Vacurect Manufacturing (Pty), Ltd.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0
2003	1	0

FIG. 1 — Lineage of K974173, 1984–2003Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K841257	Sta-Potent System Summary page 1 …uum Erection System - OTC StayErec® Tension Rings - OTC Classification Name: External Penile Rigidity Device III. Predicate Devices: ErecAid System Classic (510(k) No. K841257) ErecAid System Esteem Battery (510(k) No. K912736/A) StayErec Tension Rings (510(k) No. K901318) IV.. Description of the Device:…	Nu-Potent	1984	—
*	K912736	Erecaid (R) System Plus Summary page 1 …OTC Classification Name: External Penile Rigidity Device III. Predicate Devices: ErecAid System Classic (510(k) No. K841257) ErecAid System Esteem Battery (510(k) No. K912736/A) StayErec Tension Rings (510(k) No. K901318) IV.. Description of the Device: The Imagyn Medical Technologies, Inc. ErecAid Syst…	Osbon Medical Systems, Ltd.	1991	—
*	K901318	Stayerec System (TM) Summary page 1 …dity Device III. Predicate Devices: ErecAid System Classic (510(k) No. K841257) ErecAid System Esteem Battery (510(k) No. K912736/A) StayErec Tension Rings (510(k) No. K901318) IV.. Description of the Device: The Imagyn Medical Technologies, Inc. ErecAid System Classic vacuum erection system (“ErecAid")…	Osbon Medical Systems, Ltd.	1990	—

Also cleared against K841257: 7 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K981506	Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection…	Repro-Med Systems, Inc.	1998	2

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 3 ancestors has a recall.
Of its descendants, K981506 (Repro-Med Systems, Inc., 1998) has gone furthest, with 2 descendants of its own.
7 other devices also cite its predicate K841257.

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?

ErecAid® System-OTC and StayErec® System Tension Rings-OTC

These devices are intended for the treatment or management of erectile dysfunction/impotence.

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/K974173 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974173: Erecaid System/Stay Erec System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974173

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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