Cleared Traditional

K171021 - JO Agapé Personal Lubricant

K171021 is an FDA 510(k) clearance for JO Agapé Personal Lubricant, 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 104-day FDA review.

K171021 · United Consortium · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
104d
Days
Class 2
Risk

K171021 is an FDA 510(k) clearance for the JO Agapé 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 July 18, 2017 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all United Consortium devices

FDA 510(k) Submission Details - K171021

510(k) Number K171021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2017
Decision Date July 18, 2017
Days to Decision 104 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
56d faster than avg
Panel avg: 160d · This submission: 104d
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 K171021.
FuckWater
K171730 · Non-Friction Products, Inc. · Sep 2017
Astroglide O Oil Personal Lubricant & Massage Oil
K171985 · Biofilm, Inc. · Aug 2017
External Moisturizing Gel
K171855 · Combe Incorporated · Jul 2017
YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer
K162569 · Biotech Lubricants, Ltd. · Jun 2017
Restore Moisturizing Vaginal Lubricant
K162207 · Good Clean Love · May 2017
LUVENA VAGINAL MOISTURIZER & LUBRICANT
K162235 · Laclede, Inc. · Mar 2017