Cleared Traditional

K191214 - JO Premium Jelly Original Personal Lubr...

K191214 is the FDA 510(k) clearance for JO Premium Jelly Original Personal Lubr... by United Consortium. It is a Class 2 Obstetrics & Gynecology device (product code NUC) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K191214 · United Consortium · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
87d
Days
Class 2
Risk

K191214 is an FDA 510(k) clearance for the JO Premium Jelly Original 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 1, 2019 after a review of 87 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 K191214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2019
Decision Date August 01, 2019
Days to Decision 87 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
73d faster than avg
Panel avg: 160d · This submission: 87d
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 K191214.
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
K191480 · Trigg Laboratories, Inc. D/B/A Wet International · Oct 2019
Aloe Glide Lubricant
K190323 · Desert Harvest, Inc. · Sep 2019
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
K190858 · United Consortium · Sep 2019
Sage 2-in-1 Personal Lubricant and Moisturizer
K190150 · Fairhaven Health, LLC · Jul 2019
GLISSANT Intimate Lubricant
K183050 · Vjuvenate, LLC · Jul 2019
KY Banksy Moisture
K183505 · Rb Health (Us), LLC · May 2019