Cleared Traditional

K060145 - FDS INTIMATE AND INTIMATE WARMING LUBRICANT

K060145 is an FDA 510(k) clearance for FDS INTIMATE AND INTIMATE WARMING LUBRICANT, manufactured by Alberto-Culver USA, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K060145 · Alberto-Culver USA, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
85d
Days
Class 2
Risk

K060145 is an FDA 510(k) clearance for the FDS INTIMATE AND INTIMATE WARMING LUBRICANT. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Alberto-Culver USA, Inc. (Melrose Park, US). The FDA issued a Cleared decision on April 14, 2006 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alberto-Culver USA, Inc. devices

FDA 510(k) Submission Details - K060145

510(k) Number K060145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2006
Decision Date April 14, 2006
Days to Decision 85 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
75d faster than avg
Panel avg: 160d · This submission: 85d
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 153
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K060145.
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K003867 · Biofilm, Inc. · Mar 2001