Cleared Traditional

PRE-VA VAGINAL LUBRICANT (K072741) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072741 · Ingfertility, LLC · Obstetrics & Gynecology device
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Jul 2008
Decision
293d
Days
Class 2
Risk

K072741 is an FDA 510(k) clearance for the PRE-VA VAGINAL LUBRICANT. Classified as Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible (product code PEB), Class II - Special Controls.

Submitted by Ingfertility, LLC (Valleyford, US). The FDA issued a Cleared decision on July 16, 2008 after a review of 293 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 Ingfertility, LLC devices

Submission Details

510(k) Number K072741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2007
Decision Date July 16, 2008
Days to Decision 293 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
133d slower than avg
Panel avg: 160d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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
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