Cleared Traditional

K182027 - Wet Organics Personal Lubricant (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182027 · Trigg Laboratories Dba Wet International · Obstetrics & Gynecology device
Nov 2018
Decision
114d
Days
Class 2
Risk

K182027 is an FDA 510(k) clearance for the Wet Organics Personal Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Trigg Laboratories Dba Wet International (Las Vegas, US). The FDA issued a Cleared decision on November 21, 2018 after a review of 114 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.

Submission Details

510(k) Number K182027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2018
Decision Date November 21, 2018
Days to Decision 114 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 158d · This submission: 114d
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 11
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K182027.
Water-based lubricant
K253983 · Guangzhou Haoyimai Trading Co., Ltd. · Mar 2026
Chiavaye Personal Moisturizer
K251011 · Unipack, LLC · Dec 2025
Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)
K252935 · Foshan Pingchuang Medical Technology Co., Ltd. · Dec 2025
Cerynë Intimate Care
K250488 · Ansella Therapeutics · Dec 2025
Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant
K251773 · Shenzhen Yongquan Medical Devices Co., Ltd. · Sep 2025
Plain Water-based Lubricant
K243972 · Global Protection Corp. · Aug 2025