Cleared Traditional

DUREX PLAY MASSAGE GEL LUBRICANT (K063385) - FDA 510(k) Clearance

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

K063385 · Ssl Americas, Inc. · Obstetrics & Gynecology device
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Mar 2008
Decision
488d
Days
Class 2
Risk

K063385 is an FDA 510(k) clearance for the DUREX PLAY MASSAGE GEL 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 March 10, 2008 after a review of 488 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Ssl Americas, Inc. devices

Submission Details

510(k) Number K063385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2006
Decision Date March 10, 2008
Days to Decision 488 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
328d slower than avg
Panel avg: 160d · This submission: 488d
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.

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