Cleared Traditional

K080978 - WALGREEN'S PERSONAL LUBRICATING JELLY

K080978 is an FDA 510(k) clearance for WALGREEN'S PERSONAL LUBRICATING JELLY, manufactured by Topco Sales. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K080978 · Topco Sales · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
381d
Days
Class 2
Risk

K080978 is an FDA 510(k) clearance for the WALGREEN'S PERSONAL LUBRICATING JELLY. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Topco Sales (Chatsworth, US). The FDA issued a Cleared decision on April 23, 2009 after a review of 381 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 - K080978

510(k) Number K080978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2008
Decision Date April 23, 2009
Days to Decision 381 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
220d slower than avg
Panel avg: 161d · This submission: 381d
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 K080978.
HYALO GYN
K094039 · Fidia Farmaceutici S.P.A. · May 2010
LUBREASE FEMALE LUBRICANT
K091298 · Curves Limited · Feb 2010
PHARMAPAC PERSONAL LUBRICANT
K091554 · Pharmapac, LLC · Aug 2009
K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME
K081236 · Mcneil-Ppc, Inc. · Sep 2008
DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT
K072236 · Ssl Americas · May 2008
ELEGANCE WOMAN'S LUBRICANT
K070587 · Julie Williams, Pa-C · Apr 2008
K080978 · WALGREEN'S PERSONAL LUBRICATING JELLY
Download PDF FDA Summary Topco Sales