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 Jun 24, 2011 as substantially equivalent to K851646 (Multicept, Aps., 1985) and 1 other predicate after a 116-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.
- Decided
- Jun 24, 2011
- Review
- 116 days
- Class
- Class II
- Product code
- KXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K851646 (1985). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K142304Viberect Penile Vibratory Stimulation DeviceReflexonic, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851646 | Vibrector | Multicept, Aps. | 1985 | — |
| 0 (this device) | K110566 | Viberect Penile Vibratory Stimulation Device | Reflexonic, LLC | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (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 |
|---|---|---|---|
| * | K851646 | VibrectorSummary page 1…D an IVdncdture.. l j K851646 Vibrector MulticeptAPS -54~ K955589… | 1985 |
| * | K955589 | Ferticare Personal Therapeutic VibratorSummary page 2…IVdncdture.. l j K851646 Vibrector MulticeptAPS -54~ K955589 Ferticare Personal Therapeutic Vibrator Multicept APS 4. Description of the Device The VibereCtTM Pe… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142304 | Viberect Penile Vibratory Stimulation Device | 2014 | 0 |
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 2 ancestors has a recall.
- Of its descendants, K142304 (Reflexonic, LLC, 2014) has gone furthest, with 0 descendants of its own.
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. 2011, 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?
ViberectT Penile Vibratory Stimulation Device is a hand held medical device indicated to provoke erections for men who experience erectile dysfunction and to provoke ejaculation for spinal cord injured men.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110566 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110566: Viberect Penile Vibratory Stimulation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110566
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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