510(k) · Cleared
ClearedViberect Penile Vibratory Stimulation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reflexonic, LLC · KXQ Vibrator For Therapeutic Use, Genital
Cleared on Oct 3, 2014 as substantially equivalent to K110566 (Reflexonic, LLC, 2011) after a 46-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Oct 3, 2014
- Review
- 46 days
- Class
- Class II
- Product code
- KXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K851646 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851646 | Vibrector | Multicept, Aps. | 1985 | — |
| −1 | K110566 | Viberect Penile Vibratory Stimulation Device | Reflexonic, LLC | 2011 | — |
| 0 (this device) | K142304 | Viberect Penile Vibratory Stimulation Device | Reflexonic, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 KXQ? 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 |
|---|---|---|---|
| * | K110566 | Viberect Penile Vibratory Stimulation DeviceSummary page 4…el: Obstetrics /Gynecology 5. Legally Marketed Predicate Device(s) Viberect® Penile Vibratory Stimulation Device Manufactured by Reflexonic, LLC 510(k) K110566 Page 5-1… | 2011 |
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 29 years and passes through 2 companies; a new generation was cleared every 25.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All KXQ devicesKXQ Vibrator For Therapeutic Use, Genital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KXQ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KXQ
Too few KXQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KXQ
No recall names KXQ since 2007.
Adverse event reports per year · KXQ
1in 2024
MAUDE reports naming product code KXQ, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Viberect® Penile Vibratory Stimulation Device is a hand held medical device indicated to provoke erections for men who experience erectile dysfunction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142304: Viberect Penile Vibratory Stimulation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142304
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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