Cleared Traditional

K120706 - NIRVANA A PERSONAL LUBRICANT

K120706 is an FDA 510(k) clearance for NIRVANA A PERSONAL LUBRICANT, manufactured by Church & Dwight Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K120706 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
210d
Days
Class 2
Risk

K120706 is an FDA 510(k) clearance for the NIRVANA A PERSONAL LUBRICANT. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on October 4, 2012 after a review of 210 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 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.

View all Church & Dwight Co., Inc. devices

FDA 510(k) Submission Details - K120706

510(k) Number K120706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2012
Decision Date October 04, 2012
Days to Decision 210 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
50d slower than avg
Panel avg: 160d · This submission: 210d
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 212
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K120706.
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K122477 · Ansell Healthcare Products, LLC · Feb 2013
LIFESTYLES NATURAL PERSONAL LUBRICANT
K122054 · Ansell Healthcare Products, LLC · Feb 2013
ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER
K112217 · Polichem S.A · Oct 2012
NIRVANA B PERSONAL LUBRICANT
K120751 · Church & Dwight Co., Inc. · Oct 2012
POISE PERSONAL LUBRICANT
K120650 · Kimberly Clark Corporation · Jul 2012
ONE PERSONAL LUBRICANT (SILICONE)
K110690 · One · Mar 2012