Cleared Traditional

K220534 - Wet Essential95 Personal Lubricant (FDA 510(k) Clearance)

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

K220534 · Trigg Laboratories, Inc. · Obstetrics & Gynecology device
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Jul 2022
Decision
133d
Days
Class 2
Risk

K220534 is an FDA 510(k) clearance for the Wet Essential95 Personal Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Trigg Laboratories, Inc. (Las Vegas, US). The FDA issued a Cleared decision on July 7, 2022 after a review of 133 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. devices

Submission Details

510(k) Number K220534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2022
Decision Date July 07, 2022
Days to Decision 133 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
27d faster than avg
Panel avg: 160d · This submission: 133d
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 239
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K220534.
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