510(k) · Cleared
ClearedVacurect Vacuum Constriction Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vacurect Manufacturing (Pty), Ltd. · LKY Device, External Penile Rigidity
Cleared on Jun 5, 2002 as substantially equivalent to K981506 (Repro-Med Systems, Inc., 1998) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Jun 5, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- LKY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K841257 (1984). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK841257 Sta-Potent SystemNu-Potent · 1984
- 2 generations backK974173 Erecaid System/Stay Erec SystemImagyn Medical Technologies, Inc. · 1998
- 1 generation backK981506 Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep…Repro-Med Systems, Inc. · 1998
- This deviceK020969 Vacurect Vacuum Constriction DeviceVacurect Manufacturing (Pty), Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K841257 | Sta-Potent System | Nu-Potent | 1984 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
| 1992 | 1 | 0 |
| 1998 | 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? (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 | Decided |
|---|---|---|---|
| * | K981506 | Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection…Summary page 1…Vacuum Pump and Constriction Rings Submission Date: March 25,2002 3. PREDICATE DEVICES Repro-Med Restore Vacuum Erection Device (K981506) Imagyn Medical Technologies, Inc. Irnpower System Vacuum Erection System (K980291) 4. DEVICEDESCRIPTION Th… | 1998 |
| * | K980291 | Impower External Vacuum SystemSummary page 1…CATE DEVICES Repro-Med Restore Vacuum Erection Device (K981506) Imagyn Medical Technologies, Inc. Irnpower System Vacuum Erection System (K980291) 4. DEVICEDESCRIPTION The Vacurect Vacuum Constriction Device is an over the counter device that consists of two… | 1998 |
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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K981506.
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 Vacurect vacuum component is intended to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis. The constriction ring is intended to maintain penile rigidity in men with erectile dysfunction. The Vacurect Vacuum Constriction Device is intended for over-the-counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020969: Vacurect Vacuum Constriction Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020969
Report an extraction error
Are you the manufacturer?
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