Cleared Traditional

JO Actively Trying Personal Lubricant (K182585) - FDA 510(k) Clearance

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

K182585 · United Consortium · Obstetrics & Gynecology device
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Apr 2019
Decision
218d
Days
Class 2
Risk

K182585 is an FDA 510(k) clearance for the JO Actively Trying Personal Lubricant. Classified as Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible (product code PEB), Class II - Special Controls.

Submitted by United Consortium (Valencia, US). The FDA issued a Cleared decision on April 26, 2019 after a review of 218 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 United Consortium devices

Submission Details

510(k) Number K182585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2018
Decision Date April 26, 2019
Days to Decision 218 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
58d slower than avg
Panel avg: 160d · This submission: 218d
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
Devices cleared under the same product code (PEB) and FDA review panel - the closest regulatory comparables to K182585.
Actively Trying Personal Lubricant Rose Scented
K212885 · CC Wellness, LLC · Feb 2022
Actively Trying Personal Lubricant Unfragrance
K212705 · CC Wellness, LLC · Feb 2022
Pre-Seed™ Fertility Lubricant
K193450 · Church & Dwight Co., Inc. · Jul 2020
BioGenesis Fertility Lubricant
K190872 · Good Clean Love, Inc. · Nov 2019