Cleared Traditional

K143322 - Medline Natural Lubricating Liquid

K143322 is the FDA 510(k) clearance for Medline Natural Lubricating Liquid by Medline Industries, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code NUC) cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K143322 · Medline Industries, Inc. · Obstetrics & Gynecology device
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Jul 2015
Decision
243d
Days
Class 2
Risk

K143322 is an FDA 510(k) clearance for the Medline Natural Lubricating Liquid. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 20, 2015 after a review of 243 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.

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Submission Details

510(k) Number K143322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2014
Decision Date July 20, 2015
Days to Decision 243 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
83d slower than avg
Panel avg: 160d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.