Cleared Traditional

K162319 - BabyDance Fertility Lubricant

K162319 is the FDA 510(k) clearance for BabyDance Fertility Lubricant by Fairhaven Health, LLC. It is a Class 2 Obstetrics & Gynecology device (product code PEB) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K162319 · Fairhaven Health, LLC · Obstetrics & Gynecology device
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Apr 2017
Decision
252d
Days
Class 2
Risk

K162319 is an FDA 510(k) clearance for the BabyDance Fertility Lubricant. Classified as Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible (product code PEB), Class II - Special Controls.

Submitted by Fairhaven Health, LLC (Bellingham, US). The FDA issued a Cleared decision on April 28, 2017 after a review of 252 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.

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Submission Details

510(k) Number K162319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2016
Decision Date April 28, 2017
Days to Decision 252 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
92d slower than avg
Panel avg: 160d · This submission: 252d
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.