Cleared Traditional

K171985 - Astroglide O Oil Personal Lubricant & Massage Oil

K171985 is an FDA 510(k) clearance for Astroglide O Oil Personal Lubricant & M..., 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 58-day FDA review.

K171985 · Biofilm, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
58d
Days
Class 2
Risk

K171985 is an FDA 510(k) clearance for the Astroglide O Oil Personal Lubricant & Massage Oil. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Biofilm, Inc. (Vista, US). The FDA issued a Cleared decision on August 30, 2017 after a review of 58 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 Biofilm, Inc. devices

FDA 510(k) Submission Details - K171985

510(k) Number K171985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2017
Decision Date August 30, 2017
Days to Decision 58 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
103d faster than avg
Panel avg: 161d · This submission: 58d
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 K171985.
JO Gelato Flavored Personal Lubricants
K172447 · United Consortium · Oct 2017
Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
K163674 · Neo Cosmetique · Sep 2017
FuckWater
K171730 · Non-Friction Products, Inc. · Sep 2017
External Moisturizing Gel
K171855 · Combe Incorporated · Jul 2017
JO Agapé Personal Lubricant
K171021 · United Consortium · Jul 2017
YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer
K162569 · Biotech Lubricants, Ltd. · Jun 2017