Cleared Traditional

K171044 - Climax Personal Lubricant

K171044 is an FDA 510(k) clearance for Climax Personal Lubricant, manufactured by Wsm Investment, LLC, Dba Topco Sales. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K171044 · Wsm Investment, LLC, Dba Topco Sales · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Nov 2017
Decision
228d
Days
Class 2
Risk

K171044 is an FDA 510(k) clearance for the Climax Personal Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Wsm Investment, LLC, Dba Topco Sales (Simi Valley, US). The FDA issued a Cleared decision on November 21, 2017 after a review of 228 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 Wsm Investment, LLC, Dba Topco Sales devices

FDA 510(k) Submission Details - K171044

510(k) Number K171044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2017
Decision Date November 21, 2017
Days to Decision 228 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
68d slower than avg
Panel avg: 160d · This submission: 228d
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 K171044.
K-Y Silicone
K173504 · Reckitt Benckiser, LLC · Jan 2018
LifeStyles® SKYN® Intimate Moments Personal Lubricant
K172473 · Sxwell USA, LLC · Dec 2017
wettrust D2care
K170797 · Wettrust Korea Co., Ltd. · Dec 2017
JO Gelato Flavored Personal Lubricants
K172447 · United Consortium · Oct 2017
Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
K163674 · Neo Cosmetique · Sep 2017
FuckWater
K171730 · Non-Friction Products, Inc. · Sep 2017