Cleared Traditional

K150480 - JO H20 Water Based Personal Lubricant

K150480 is an FDA 510(k) clearance for JO H20 Water Based Personal Lubricant, manufactured by United Consortium, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K150480 · United Consortium, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
134d
Days
Class 2
Risk

K150480 is an FDA 510(k) clearance for the JO H20 Water Based Personal Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by United Consortium, Inc. (Valencia, US). The FDA issued a Cleared decision on July 8, 2015 after a review of 134 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.

FDA 510(k) Submission Details - K150480

510(k) Number K150480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2015
Decision Date July 08, 2015
Days to Decision 134 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: 161d · This submission: 134d
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 248
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K150480.
O Glide Personal Lubricant
K142726 · Grafenberg Labs · Jul 2015
Medline Natural Lubricating Liquid
K143322 · Medline Industries, Inc. · Jul 2015
Trojan Riviera Personal Lubricant
K150886 · Church & Dwight Co., Inc. · Jul 2015
K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant
K143511 · Reckitt Benckiser · May 2015
Vaginal Moisturizing Gel
K150615 · Combe Incorporated · May 2015
JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL
K140506 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · Apr 2015