Cleared Special

K070545 - K-Y BRAND WARMING LIQUID

K070545 is an FDA 510(k) clearance for K-Y BRAND WARMING LIQUID, manufactured by Personal Products Co.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Special 510(k) pathway after a 25-day FDA review.

K070545 · Personal Products Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
25d
Days
Class 2
Risk

K070545 is an FDA 510(k) clearance for the K-Y BRAND WARMING LIQUID. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Personal Products Co. (Skillman, US). The FDA issued a Cleared decision on March 23, 2007 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070545

510(k) Number K070545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2007
Decision Date March 23, 2007
Days to Decision 25 days
Submission Type Special
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
136d faster than avg
Panel avg: 161d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K070545.
K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
K072360 · Mcneil-Ppc, Inc. · Dec 2007
PHARMAPAC LUBRICATING JELLY
K070623 · Pharmapac, LLC · Aug 2007
CVS PERSONAL LUBRICANT AND MOISTURIZER
K062682 · Lake Consumer Products, Inc. · Apr 2007
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
K070545 · K-Y BRAND WARMING LIQUID
Download PDF FDA Summary Personal Products Co.