Cleared Traditional

K051688 - FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS

K051688 is an FDA 510(k) clearance for FOR PLAY, manufactured by Trimensa Pharmaceuticals. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K051688 · Trimensa Pharmaceuticals · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
384d
Days
Class 2
Risk

K051688 is an FDA 510(k) clearance for the FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Trimensa Pharmaceuticals (Newbury Park, US). The FDA issued a Cleared decision on July 12, 2006 after a review of 384 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K051688

510(k) Number K051688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2005
Decision Date July 12, 2006
Days to Decision 384 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
223d slower than avg
Panel avg: 161d · This submission: 384d
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 K051688.
K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING
K062535 · Mcneil-Ppc, Inc. · Jan 2007
K-Y BRAND INTRIGUE
K062796 · Personal Products Co. · Dec 2006
INTIMOL
K061466 · Dlc Laboratories, Inc. · Dec 2006
DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS
K060098 · Ssl Americas, Inc. · Jun 2006
FDS INTIMATE AND INTIMATE WARMING LUBRICANT
K060145 · Alberto-Culver USA, Inc. · Apr 2006
K-Y BRAND SENSUAL MIST
K053397 · Mcneil-Ppc, Inc. · Feb 2006
K051688 · FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS
Download PDF FDA Summary Trimensa Pharmaceutic…