Cleared Traditional

K072647 - GLYCERIN & PARABEN FREE ASTROGLIDE

K072647 is an FDA 510(k) clearance for GLYCERIN & PARABEN FREE ASTROGLIDE, manufactured by Biofilm, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K072647 · Biofilm, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
128d
Days
Class 2
Risk

K072647 is an FDA 510(k) clearance for the GLYCERIN & PARABEN FREE ASTROGLIDE. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Biofilm, Inc. (Vista, US). The FDA issued a Cleared decision on January 25, 2008 after a review of 128 days - within the typical 510(k) review window.

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.

View all Biofilm, Inc. devices

FDA 510(k) Submission Details - K072647

510(k) Number K072647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2007
Decision Date January 25, 2008
Days to Decision 128 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
33d faster than avg
Panel avg: 161d · This submission: 128d
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 K072647.
DUREX PLAY SOFT & SENSUAL LUBRICANT
K071626 · Ssl Americas · Apr 2008
DUREX PLAY MASSAGE GEL LUBRICANT
K063385 · Ssl Americas, Inc. · Mar 2008
K-Y BRAND YOURS+MINE
K072421 · Mcneil-Ppc, Inc. · Mar 2008
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