Cleared Abbreviated

K042958 - DUREX PLAY TINGLING LUBRICANT

K042958 is an FDA 510(k) clearance for DUREX PLAY TINGLING LUBRICANT, manufactured by Ssl Americas, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Abbreviated 510(k) pathway after a 163-day FDA review.

K042958 · Ssl Americas, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
163d
Days
Class 2
Risk

K042958 is an FDA 510(k) clearance for the DUREX PLAY TINGLING LUBRICANT. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Ssl Americas, Inc. (Norcross, US). The FDA issued a Cleared decision on April 8, 2005 after a review of 163 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K042958

510(k) Number K042958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2004
Decision Date April 08, 2005
Days to Decision 163 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 161d · This submission: 163d
Pathway characteristics
Standards-based clearance path.

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 K042958.
O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT
K042915 · O'My Products Incorporated · Aug 2005
MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSING, EROZONE BODYGLIDE NATURAL FOAM
K040428 · R & K International Cosmetics · Aug 2005
THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT
K051668 · Goodmark USA, Inc. · Jul 2005
PERSONAL WARMING GEL
K050211 · Qualis, Inc. · Mar 2005
PERSONAL WARMING JELLY
K050212 · Qualis, Inc. · Mar 2005
PERSONAL LUBRICATING GEL
K041129 · Qualis, Inc. · Sep 2004
K042958 · DUREX PLAY TINGLING LUBRICANT
Download PDF FDA Summary Ssl Americas, Inc.