Cleared Traditional

K122061 - K-Y BRAND LIQUIBEADS

K122061 is an FDA 510(k) clearance for K-Y BRAND LIQUIBEADS, manufactured by Johnson & Johnson Healthcare Products. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 483-day FDA review.

K122061 · Johnson & Johnson Healthcare Products · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
483d
Days
Class 2
Risk

K122061 is an FDA 510(k) clearance for the K-Y BRAND LIQUIBEADS. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Johnson & Johnson Healthcare Products (Morris Plains, US). The FDA issued a Cleared decision on November 8, 2013 after a review of 483 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Johnson & Johnson Healthcare Products devices

FDA 510(k) Submission Details - K122061

510(k) Number K122061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2012
Decision Date November 08, 2013
Days to Decision 483 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
322d slower than avg
Panel avg: 161d · This submission: 483d
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 244
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K122061.
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
JO PREMIUM PERSONAL LUBRICANT
K132954 · United Consortium · Jun 2014
SASMAR ORIGINAL, SASMAR CLASSIC
K131084 · Sasmar, Inc. · Sep 2013
ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS
K124044 · Seven Oaks Ranch, Inc. · Aug 2013
WET PLATINUM PERSONAL LUBRICANT
K130012 · Trigg Laboratories, Inc. · Aug 2013