Cleared Traditional

K181408 - JO Classic Hybrid Personal Lubricant

K181408 is the FDA 510(k) clearance for JO Classic Hybrid Personal Lubricant by United Consortium. It is a Class 2 Obstetrics & Gynecology device (product code NUC) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K181408 · United Consortium · Obstetrics & Gynecology device
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Aug 2018
Decision
89d
Days
Class 2
Risk

K181408 is an FDA 510(k) clearance for the JO Classic Hybrid Personal Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by United Consortium (Valencia, US). The FDA issued a Cleared decision on August 27, 2018 after a review of 89 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

Submission Details

510(k) Number K181408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2018
Decision Date August 27, 2018
Days to Decision 89 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
71d faster than avg
Panel avg: 160d · This submission: 89d
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 K181408.
Wet Organics Personal Lubricant
K182027 · Trigg Laboratories Dba Wet International · Nov 2018
JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant
K182105 · United Consortium · Nov 2018
The Sex Gel
K181078 · Necessaire, Inc. · Sep 2018
TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)
K180764 · Church & Dwight Co., Inc. · Aug 2018
Personal Lubricating Jelly
K180923 · Perrigo New York, Inc. · Jul 2018
Coconut Infused Hybrid Personal Lubricant
K180712 · United Consortium · Jun 2018