Cleared Traditional

K150615 - Vaginal Moisturizing Gel

K150615 is the FDA 510(k) clearance for Vaginal Moisturizing Gel by Combe Incorporated. It is a Class 2 Obstetrics & Gynecology device (product code NUC) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K150615 · Combe Incorporated · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
52d
Days
Class 2
Risk

K150615 is an FDA 510(k) clearance for the Vaginal Moisturizing Gel. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Combe Incorporated (White Plains, US). The FDA issued a Cleared decision on May 1, 2015 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Combe Incorporated devices

Submission Details

510(k) Number K150615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2015
Decision Date May 01, 2015
Days to Decision 52 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 160d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUC Lubricant, Personal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.
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.

Regulatory Peers - NUC Lubricant, Personal

All 121
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K150615.
K-Y Silicone
K173504 · Reckitt Benckiser, LLC · Jan 2018
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
K143529 · Medline Industries, Inc. · Aug 2015
Medline Natural Lubricating Liquid
K143322 · Medline Industries, Inc. · Jul 2015
K-Y BRAND WARMING LIQUID
K070545 · Personal Products Co. · Mar 2007
K-Y BRAND INTRIGUE
K062796 · Personal Products Co. · Dec 2006
TROJAN PASSION BERRY GEL
K013433 · Armkel, LLC · Mar 2002