Cleared Traditional

K132954 - JO PREMIUM PERSONAL LUBRICANT

K132954 is an FDA 510(k) clearance for JO PREMIUM 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 264-day FDA review.

K132954 · United Consortium · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
264d
Days
Class 2
Risk

K132954 is an FDA 510(k) clearance for the JO PREMIUM 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 June 11, 2014 after a review of 264 days - an extended review 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: 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 - K132954

510(k) Number K132954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2013
Decision Date June 11, 2014
Days to Decision 264 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
104d slower than avg
Panel avg: 160d · This submission: 264d
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 K132954.
PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
K133336 · Pjur Group Luxembourg S.A. · Jul 2014
AZUL PERSONAL LUBRICANT
K141034 · Church & Dwight Co., Inc. · Jul 2014
PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE
K133233 · Pjur Group Luxembourg S.A. · Jul 2014
K-Y BRAND LIQUIBEADS
K122061 · Johnson & Johnson Healthcare Products · Nov 2013
SASMAR ORIGINAL, SASMAR CLASSIC
K131084 · Sasmar, Inc. · Sep 2013
ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS
K124044 · Seven Oaks Ranch, Inc. · Aug 2013