Cleared Special

K010096 - MULTI CARE THERAPEUTIC VIBRATOR

K010096 is an FDA 510(k) clearance for MULTI CARE THERAPEUTIC VIBRATOR, manufactured by Multicept A/S. The device is a Class 2 Obstetrics & Gynecology device with product code KXQ cleared through the Special 510(k) pathway after a 53-day FDA review.

K010096 · Multicept A/S · Obstetrics & Gynecology device
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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.

FDA 510(k) Submission Details - K010096

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 161d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

KXQ Device Classification - Class 2, Special Controls

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.

K010096 · MULTI CARE THERAPEUTIC VIBRATOR
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