510(k) · Cleared
ClearedRestore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum Erection Dev)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Repro-Med Systems, Inc. · LKY Device, External Penile Rigidity
Cleared on Jun 25, 1998 as substantially equivalent to K841257 (Nu-Potent, 1984) and 2 other predicates after a 59-day review. Its family tree reaches back 2 generations to 1984. 2 later devices descend from it.
- Decided
- Jun 25, 1998
- Review
- 59 days
- Class
- Class II
- Product code
- LKY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K841257 (1984). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK841257 Sta-Potent SystemNu-Potent · 1984
- 1 generation backK974173 Erecaid System/Stay Erec SystemImagyn Medical Technologies, Inc. · 1998
- This deviceK981506 Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep…Repro-Med Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK032776 Vacurect Vacuum Constriction DeviceVacurect Manufacturing (Pty), Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK020969 Vacurect Vacuum Constriction DeviceVacurect Manufacturing (Pty), Ltd. · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K841257 | Sta-Potent System | Nu-Potent | 1984 | — |
| −1 | K974173 | Erecaid System/Stay Erec System | Imagyn Medical Technologies, Inc. | 1998 | — |
| 0 (this device) | K981506 | Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile… | Repro-Med Systems, Inc. | 1998 | — |
| +1 | K032776 | Vacurect Vacuum Constriction Device | Vacurect Manufacturing (Pty), Ltd. | 2003 | — |
| +1 | K020969 | Vacurect Vacuum Constriction Device | Vacurect Manufacturing (Pty), Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K841257 | Sta-Potent SystemSummary page 2…Vacuum Erection Device Common Name; Extemal Penile Rigidity Device Classification Name: Vacuum Pump And Constriction Rings Predicate Device(s): Erecaid System Classic (K841257) Erecaid System / Stay Erec System (K974173) Pro-Long Rings (K904485) Device Description: The RESTORE Vacuum Erection Device c… | 1984 |
| * | K974173 | Erecaid System/Stay Erec SystemSummary page 2…Penile Rigidity Device Classification Name: Vacuum Pump And Constriction Rings Predicate Device(s): Erecaid System Classic (K841257) Erecaid System / Stay Erec System (K974173) Pro-Long Rings (K904485) Device Description: The RESTORE Vacuum Erection Device consiéts of a vacuum pump, ABS p!a§tic vacuum… | 1998 |
| * | K904485 | Support RingSummary page 2…lassification Name: Vacuum Pump And Constriction Rings Predicate Device(s): Erecaid System Classic (K841257) Erecaid System / Stay Erec System (K974173) Pro-Long Rings (K904485) Device Description: The RESTORE Vacuum Erection Device consiéts of a vacuum pump, ABS p!a§tic vacuum cylinder, connecting PVC… | 1990 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 13.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K032776 (Vacurect Manufacturing (Pty), Ltd., 2003) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K841257.
How does its category compare?
All LKY devicesLKY 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
MAUDE reports naming product code LKY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
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/K981506 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981506: Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum Erection Dev).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981506
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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