Cleared Traditional

K180014 - Creme de La Femme Feminine Lubricant (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180014 · Cewal, Inc. Dba Premiere Enterprises · Obstetrics & Gynecology device
Dec 2018
Decision
353d
Days
Class 2
Risk

K180014 is an FDA 510(k) clearance for the Creme de La Femme Feminine Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Cewal, Inc. Dba Premiere Enterprises (Los Angeles, US). The FDA issued a Cleared decision on December 21, 2018 after a review of 353 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.

Submission Details

510(k) Number K180014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2018
Decision Date December 21, 2018
Days to Decision 353 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 158d · This submission: 353d
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.

Regulatory Peers - NUC Lubricant, Personal

All 11
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K180014.
Water-based lubricant
K253983 · Guangzhou Haoyimai Trading Co., Ltd. · Mar 2026
Chiavaye Personal Moisturizer
K251011 · Unipack, LLC · Dec 2025
Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)
K252935 · Foshan Pingchuang Medical Technology Co., Ltd. · Dec 2025
Cerynë Intimate Care
K250488 · Ansella Therapeutics · Dec 2025
Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant
K251773 · Shenzhen Yongquan Medical Devices Co., Ltd. · Sep 2025
Plain Water-based Lubricant
K243972 · Global Protection Corp. · Aug 2025