Cleared Traditional

K062796 - K-Y BRAND INTRIGUE

K062796 is the FDA 510(k) clearance for K-Y BRAND INTRIGUE by Personal Products Co.. It is a Class 2 Obstetrics & Gynecology device (product code NUC) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K062796 · Personal Products Co. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Dec 2006
Decision
80d
Days
Class 2
Risk

K062796 is an FDA 510(k) clearance for the K-Y BRAND INTRIGUE. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Personal Products Co. (Skillman, US). The FDA issued a Cleared decision on December 8, 2006 after a review of 80 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 Personal Products Co. devices

Submission Details

510(k) Number K062796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2006
Decision Date December 08, 2006
Days to Decision 80 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 160d · This submission: 80d
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 120
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K062796.
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
TROJAN PASSION BERRY GEL
K013433 · Armkel, LLC · Mar 2002
TROJAN CRYSTAL CLEAR LIQUID
K013614 · Armkel, LLC · Feb 2002