Cleared Traditional

K150153 - Swiss Navy Premium Silicone Lubricant

Also marketed or referenced as:
Swiss Navy Premium Water Based Lubricant Swiss Navy Premium All Natural Lubricant

K150153 is an FDA 510(k) clearance for Swiss Navy Premium Silicone Lubricant, manufactured by Package Solutions, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K150153 · Package Solutions, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
270d
Days
Class 2
Risk

K150153 is an FDA 510(k) clearance for the Swiss Navy Premium Silicone Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Package Solutions, LLC (Pompano Beach, US). The FDA issued a Cleared decision on October 20, 2015 after a review of 270 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.

FDA 510(k) Submission Details - K150153

510(k) Number K150153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2015
Decision Date October 20, 2015
Days to Decision 270 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
109d slower than avg
Panel avg: 161d · This submission: 270d
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 K150153.
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
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Divine 9
K150397 · Carrashield Labs, Inc. · Nov 2015
Uberlube
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Gynomunal
K143349 · Polichem S.A · Sep 2015
HyaloGYN Vaginal Hydrating Gel
K150883 · Fidia Farmaceutici S.P.A. · Sep 2015