Cleared Traditional

K191480 - Wet Water Based Personal Lubricant (add...

K191480 is the FDA 510(k) clearance for Wet Water Based Personal Lubricant (add... by Trigg Laboratories, Inc. D/B/A Wet International. It is a Class 2 Obstetrics & Gynecology device (product code NUC) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K191480 · Trigg Laboratories, Inc. D/B/A Wet International · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
129d
Days
Class 2
Risk

K191480 is an FDA 510(k) clearance for the Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Hou.... Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Trigg Laboratories, Inc. D/B/A Wet International (Las Vegas, US). The FDA issued a Cleared decision on October 11, 2019 after a review of 129 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 Trigg Laboratories, Inc. D/B/A Wet International devices

Submission Details

510(k) Number K191480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2019
Decision Date October 11, 2019
Days to Decision 129 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
31d faster than avg
Panel avg: 160d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 120
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K191480.
HyaloGYN Vaginal Moisturizing Suppositories
K191052 · Fidia Farmaceutici S.P.A. · Jan 2020
Satisfaite
K190752 · Femmepharma Consumer Healthcare, LLC · Dec 2019
Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant,
K192204 · Valencia Naturals, Inc. · Nov 2019
Aloe Glide Lubricant
K190323 · Desert Harvest, Inc. · Sep 2019
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
K190858 · United Consortium · Sep 2019
JO Premium Jelly Original Personal Lubricant
K191214 · United Consortium · Aug 2019