Cleared Traditional

K130345 - AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING

K130345 is an FDA 510(k) clearance for AQUA LUBE NATURAL LUBRICANT - REGULAR, manufactured by Mayer Laboratories, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K130345 · Mayer Laboratories, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
171d
Days
Class 2
Risk

K130345 is an FDA 510(k) clearance for the AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Mayer Laboratories, Inc. (Berkely, US). The FDA issued a Cleared decision on August 1, 2013 after a review of 171 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.

FDA 510(k) Submission Details - K130345

510(k) Number K130345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2013
Decision Date August 01, 2013
Days to Decision 171 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
10d slower than avg
Panel avg: 161d · This submission: 171d
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 248
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K130345.
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
NIRVANA D PERSONAL LUBRICANT (TBD)
K123427 · Church & Dwight Co., Inc. · Jun 2013
WARMING JELLY PERSONAL LUBRICANT
K123770 · Wisconsin Pharmacal Co., LLC · Apr 2013
LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
K122476 · Ansell Healthcare Products, LLC · Mar 2013