Cleared Traditional

K203377 - VR101 Lubricating Intravaginal Ring (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence.

K203377 · J3 Bioscience, Inc. · Obstetrics & Gynecology device
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May 2021
Decision
184d
Days
Class 2
Risk

K203377 is an FDA 510(k) clearance for the VR101 Lubricating Intravaginal Ring. Classified as Personal Lubricant Ring (product code QPD), Class II - Special Controls.

Submitted by J3 Bioscience, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 20, 2021 after a review of 184 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 J3 Bioscience, Inc. devices

Submission Details

510(k) Number K203377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2020
Decision Date May 20, 2021
Days to Decision 184 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
24d slower than avg
Panel avg: 160d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QPD Personal Lubricant Ring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition This Device Is A Personal Lubricant, For 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, Polyurethane, And/or Internal Condoms.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02029053 Completed Interventional Industry-sponsored

Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness

VR101: A Pilot Study to Evaluate the Preliminary Feasibility and Safety of a Lubricating Intravaginal Ring to Relieve the Symptoms of Vaginal Dryness

21
Patients (actual)
1
Site
Supportive_care
Purpose
Open label
Masking
Condition studied Menopausal and Perimenopausal Disorder, Unspecified; Atrophic Vaginitis
Study design Single group
Eligibility Female only · 35 Years+
Principal investigator Margit Janat-Amsbury, MD, PhD
Sponsor J3 Bioscience, Inc. (industry)
Started 2014-01-01 → Primary completion 2014-05-01
Primary outcome
Vaginal lubrication/moisturization
Secondary outcome
Comfort and fit of intravaginal ring
Study completed - no results published. This trial concluded in 2014 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov