FDA product code KXQ: Vibrator For Therapeutic Use, Genital
KXQ is the FDA product code for vibrator for therapeutic use, genital. It is a Class II device, regulated under 21 CFR 884.5960 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 4 510(k) submissions under KXQ, from 3 different applicants. The average 510(k) review took 85 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Vibrator For Therapeutic Use, Genital |
| Device class | Class II |
| Regulation | 21 CFR 884.5960 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KXQ clearance
Top KXQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Reflexonic, LLC | 2 | 2014-10-03 |
| Multicept A/S | 1 | 2001-03-05 |
| Multicept, Aps. | 1 | 1996-04-11 |
Most recent KXQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142304 | Reflexonic, LLC | Viberect Penile Vibratory Stimulation Device | 2014-10-03 | 46 |
| K110566 | Reflexonic, LLC | VIBERECT PENILE VIBRATORY STIMULATION DEVICE | 2011-06-24 | 116 |
| K010096 | Multicept A/S | MULTI CARE THERAPEUTIC VIBRATOR | 2001-03-05 | 53 |
| K955589 | Multicept, Aps. | FERTICARE PERSONAL THERAPEUTIC VIBRATOR | 1996-04-11 | 126 |
Recalls for KXQ devices
openFDA lists no recalls for product code KXQ.
Frequently asked questions
What is FDA product code KXQ?
KXQ is the FDA product code for vibrator for therapeutic use, genital. It is a Class II device, regulated under 21 CFR 884.5960 and reviewed by the Obstetrics and Gynecology panel.
What device class is KXQ?
Class II, regulation 21 CFR 884.5960. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KXQ?
Across 4 cleared submissions the average was 85 days from receipt to decision (median 84).
Which companies have the most KXQ clearances?
Reflexonic, LLC (2); Multicept A/S (1); Multicept, Aps. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KXQ
- Run a recall and safety report across every KXQ manufacturer
- Watch product code KXQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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