Cleared Traditional

K141132 - ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT

K141132 is an FDA 510(k) clearance for ASTROGLIDE TTC FERTILITY FRIENDLY PERSO..., manufactured by Biofilm, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code PEB cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K141132 · Biofilm, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
253d
Days
Class 2
Risk

K141132 is an FDA 510(k) clearance for the ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT. Classified as Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible (product code PEB), Class II - Special Controls.

Submitted by Biofilm, Inc. (Vista, US). The FDA issued a Cleared decision on January 9, 2015 after a review of 253 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.

View all Biofilm, Inc. devices

FDA 510(k) Submission Details - K141132

510(k) Number K141132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2014
Decision Date January 09, 2015
Days to Decision 253 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
92d slower than avg
Panel avg: 161d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PEB Device Classification - Class 2, Special Controls

Product Code PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Sexual Activity And Supplement The Body's Natural Lubrication. This Device May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms. This Device Is Compatible With Sperm, Oocytes, And Embryos And Can Be Used By Couples Trying To Conceive. This Device May Also Be Used During Fertility Interventions To Facilitate Entry Of Diagnostic And Therapeutic Devices.
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 - PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

All 9
Devices cleared under the same product code (PEB) and FDA review panel - the closest regulatory comparables to K141132.
BioGenesis Fertility Lubricant
K190872 · Good Clean Love, Inc. · Nov 2019
JO Actively Trying Personal Lubricant
K182585 · United Consortium · Apr 2019
BabyDance Fertility Lubricant
K162319 · Fairhaven Health, LLC · Apr 2017
CONCEIVE PLUS
K131355 · Sasmar, Inc. · Nov 2013
PRE-VA VAGINAL LUBRICANT
K072741 · Ingfertility, LLC · Jul 2008
PRE' VAGINAL LUBRICANT
K051436 · Ingfertlity, LLC · Oct 2006