510(k) · Cleared
ClearedImpower External Vacuum System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imagyn Medical Technologies, Inc. · LKY Device, External Penile Rigidity
Cleared on Mar 11, 1998 as substantially equivalent to K920409 (Dacomed Corp., 1992) after a 44-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Mar 11, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- LKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920409 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK920409 Dacomed Battery Operated Vacuum Erection DeviceDacomed Corp. · 1992
- This deviceK980291 Impower External Vacuum SystemImagyn Medical Technologies, 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 |
|---|---|---|---|---|---|
| −1 | K920409 | Dacomed Battery Operated Vacuum Erection Device | Dacomed Corp. | 1992 | — |
| 0 (this device) | K980291 | Impower External Vacuum System | Imagyn Medical Technologies, Inc. | 1998 | — |
| +1 | K032776 | Vacurect Vacuum Constriction Device | Vacurect Manufacturing (Pty), Ltd. | 2003 | — |
| +1 | K020969 | Vacurect Vacuum Constriction Device | Vacurect Manufacturing (Pty), Ltd. | 2002 | — |
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? (1)
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 |
|---|---|---|---|
| * | K920409 | Dacomed Battery Operated Vacuum Erection DeviceSummary page 1…evice Name: Impower System Vacuum Erection System - OTC Classification Name: External Penile Rigidity Device Predicate Devices: Impower (Catalyst) System (510(k) No. K920409) Description of the Device: The Imagyn Medical Technologies, Inc.’s Impower System vacuum erection device (“Impower") consists… | 1992 |
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?
- Its one ancestor has no recall.
- Of its descendants, K032776 (Vacurect Manufacturing (Pty), Ltd., 2003) has gone furthest, with 0 descendants of its own.
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?
This device is 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/K980291 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980291: Impower External Vacuum System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980291
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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