Cleared Traditional

K160763 - ally Liquid Personal Lubricant

K160763 is an FDA 510(k) clearance for ally Liquid Personal Lubricant, manufactured by Private Label Production, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K160763 · Private Label Production, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
100d
Days
Class 2
Risk

K160763 is an FDA 510(k) clearance for the ally Liquid Personal Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Private Label Production, LLC (Bonita Spring, US). The FDA issued a Cleared decision on June 29, 2016 after a review of 100 days - within the typical 510(k) review window.

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 Private Label Production, LLC devices

FDA 510(k) Submission Details - K160763

510(k) Number K160763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2016
Decision Date June 29, 2016
Days to Decision 100 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
60d faster than avg
Panel avg: 160d · This submission: 100d
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 131
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K160763.
Flip Lube
K171516 · Imquest Biosciences, Inc. · Feb 2018
K-Y Silicone
K173504 · Reckitt Benckiser, LLC · Jan 2018
Trojan Chain Reaction Personal Lubricant
K161544 · Church & Dwight Co., Inc. · Aug 2016
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
K143529 · Medline Industries, Inc. · Aug 2015
Medline Natural Lubricating Liquid
K143322 · Medline Industries, Inc. · Jul 2015
Trojan Riviera Personal Lubricant
K150886 · Church & Dwight Co., Inc. · Jul 2015