Cleared Traditional

K192203 - JO for Him H2O Gel Original Personal Lu...

K192203 is the FDA 510(k) clearance for JO for Him H2O Gel Original Personal Lu... by United Consortium. It is a Class 2 Obstetrics & Gynecology device (product code NUC) cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K192203 · United Consortium · Obstetrics & Gynecology device
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Feb 2020
Decision
180d
Days
Class 2
Risk

K192203 is an FDA 510(k) clearance for the JO for Him H2O Gel Original Personal Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by United Consortium (Valencia, US). The FDA issued a Cleared decision on February 10, 2020 after a review of 180 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 United Consortium devices

Submission Details

510(k) Number K192203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2019
Decision Date February 10, 2020
Days to Decision 180 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
20d slower than avg
Panel avg: 160d · This submission: 180d
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 K192203.
SILICONE Personal Lubricant
K191654 · Bath Concept Cosmetics (Dongguan) Co., Ltd. · Apr 2020
KY Grosz UltraGel
K192982 · Rb Health (Us), LLC · Apr 2020
BioNourish Lubricant
K193448 · Good Clean Love, Inc. · Mar 2020
Ah!Yes Ob Coco Personal Lubricant
K191411 · Bio-Tech Lubricants, Ltd. · Feb 2020
HyaloGYN Vaginal Moisturizing Suppositories
K191052 · Fidia Farmaceutici S.P.A. · Jan 2020
Satisfaite
K190752 · Femmepharma Consumer Healthcare, LLC · Dec 2019