510(k) Report

510(k) · Cleared

Cleared

Ferticare Personal Therapeutic Vibrator

K955589510(k) TraditionalCleared Apr 11, 1996126-day reviewClass II21 CFR 884.5960

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Multicept, Aps. · KXQ Vibrator For Therapeutic Use, Genital

Cleared on Apr 11, 1996 after a 126-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 11, 1996
Review
126 days
Class
Class II
Product code
KXQ
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2014: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955589 Ferticare Personal Therapeutic VibratorMulticept, Aps. · 1996
  2. Descendant · cites it directly · 1 of its ownK110566 Viberect Penile Vibratory Stimulation DeviceReflexonic, LLC · 2011
  3. Descendant · 2 generations on · 0 of its ownK142304 Viberect Penile Vibratory Stimulation DeviceReflexonic, LLC · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K110566Viberect Penile Vibratory Stimulation DeviceReflexonic, LLC · 2011 · cites it directly1descendant
  • K142304Viberect Penile Vibratory Stimulation DeviceReflexonic, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955589Ferticare Personal Therapeutic VibratorMulticept, Aps.1996—
+1K110566Viberect Penile Vibratory Stimulation DeviceReflexonic, LLC2011—
+2K142304Viberect Penile Vibratory Stimulation DeviceReflexonic, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201410
FIG. 1 — Lineage of K955589, 1996–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110566Viberect Penile Vibratory Stimulation DeviceReflexonic, LLC20111

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?

  • Of its descendants, K110566 (Reflexonic, LLC, 2011) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KXQ devices

KXQ Vibrator For Therapeutic Use, Genital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXQ

1in 2014

2011: 12014: 1
2007high 1 (2011) · low 0 (2007)2026

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

2022: 12023: 12024: 1
2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code KXQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—01
20240—01
20250—00
20260—0—
Cite this page

510(k) Report. “K955589: Ferticare Personal Therapeutic Vibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955589

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026