Cleared Traditional

K172447 - JO Gelato Flavored Personal Lubricants

K172447 is an FDA 510(k) clearance for JO Gelato Flavored Personal Lubricants, manufactured by United Consortium. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K172447 · United Consortium · Obstetrics & Gynecology device
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Oct 2017
Decision
78d
Days
Class 2
Risk

K172447 is an FDA 510(k) clearance for the JO Gelato Flavored Personal Lubricants. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by United Consortium (Valencia, US). The FDA issued a Cleared decision on October 31, 2017 after a review of 78 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 United Consortium devices

FDA 510(k) Submission Details - K172447

510(k) Number K172447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2017
Decision Date October 31, 2017
Days to Decision 78 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
82d faster than avg
Panel avg: 160d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUC Device Classification - Class 2, Special Controls

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 212
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K172447.
LifeStyles® SKYN® Intimate Moments Personal Lubricant
K172473 · Sxwell USA, LLC · Dec 2017
wettrust D2care
K170797 · Wettrust Korea Co., Ltd. · Dec 2017
Climax Personal Lubricant
K171044 · Wsm Investment, LLC, Dba Topco Sales · Nov 2017
Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
K163674 · Neo Cosmetique · Sep 2017
FuckWater
K171730 · Non-Friction Products, Inc. · Sep 2017
Astroglide O Oil Personal Lubricant & Massage Oil
K171985 · Biofilm, Inc. · Aug 2017