Cleared Traditional

K040340 - K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT

K040340 is an FDA 510(k) clearance for K-Y BRAND WARMING ULTRAGEL PERSONAL LUB..., manufactured by Personal Products Company, Div. of Mcneil-Ppc, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K040340 · Personal Products Company, Div. of Mcneil-Ppc, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
77d
Days
Class 2
Risk

K040340 is an FDA 510(k) clearance for the K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Personal Products Company, Div. of Mcneil-Ppc, Inc. (Skillman, US). The FDA issued a Cleared decision on April 28, 2004 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040340

510(k) Number K040340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2004
Decision Date April 28, 2004
Days to Decision 77 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
84d faster than avg
Panel avg: 161d · This submission: 77d
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 K040340.
PERSONAL WARMING JELLY
K050212 · Qualis, Inc. · Mar 2005
PERSONAL LUBRICATING GEL
K041129 · Qualis, Inc. · Sep 2004
INSTEAD INTIMATE LUBRICANT
K033776 · Instead, Inc. · Jun 2004
K-Y BRAND WARMING JELLY PERSONAL LUBRICANT
K040164 · Personal Products Company, Div. of Mcneil-Ppc, Inc. · Apr 2004
REPHRESH VAGINAL GEL
K021737 · Columbia Laboratories, Inc. · Aug 2002
K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT
K021492 · Personal Products Co., Div. of Mcneil Ppc, Inc. · Aug 2002
K040340 · K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT
Download PDF FDA Summary Personal Products Com…