Cleared Special

MULTI CARE THERAPEUTIC VIBRATOR (K010096) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010096 · Multicept A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
53d
Days
Class 2
Risk

K010096 is an FDA 510(k) clearance for the MULTI CARE THERAPEUTIC VIBRATOR. Classified as Vibrator For Therapeutic Use, Genital (product code KXQ), Class II - Special Controls.

Submitted by Multicept A/S (Hoersholm, DK). The FDA issued a Cleared decision on March 5, 2001 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5960 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Multicept A/S devices

Submission Details

510(k) Number K010096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2001
Decision Date March 05, 2001
Days to Decision 53 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 160d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KXQ Vibrator For Therapeutic Use, Genital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5960
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.