Cleared Traditional

K183384 - JO Agape Original Personal Lubricant

K183384 is the FDA 510(k) clearance for JO Agape Original 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 88-day FDA review.

K183384 · United Consortium · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
88d
Days
Class 2
Risk

K183384 is an FDA 510(k) clearance for the JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #Lu.... Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by United Consortium (Valencia, US). The FDA issued a Cleared decision on March 4, 2019 after a review of 88 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 K183384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2018
Decision Date March 04, 2019
Days to Decision 88 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
72d faster than avg
Panel avg: 160d · This submission: 88d
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 K183384.
Smile Makers Personal Lubricant
K182100 · Lfbeauty (Thailand) Limited · Apr 2019
JO H2O Jelly Original Personal Lubricant
K183584 · United Consortium · Apr 2019
KY Banksy Aloe
K183302 · Rb Health (Us), LLC · Apr 2019
Creme de La Femme Feminine Lubricant
K180014 · Cewal, Inc. Dba Premiere Enterprises · Dec 2018
Natureplex Warm Touch Warming Jelly
K180828 · Natureplex, LLC · Dec 2018
Wet Organics Personal Lubricant
K182027 · Trigg Laboratories Dba Wet International · Nov 2018