Cleared Traditional

Revive Reusable Bladder Support (K183468) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K183468 · Rinovum Subsidiary 2, LLC · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 2019
Decision
42d
Days
Class 2
Risk

K183468 is an FDA 510(k) clearance for the Revive Reusable Bladder Support. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Rinovum Subsidiary 2, LLC (Monroeville, US). The FDA issued a Cleared decision on January 25, 2019 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.3575 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rinovum Subsidiary 2, LLC devices

Submission Details

510(k) Number K183468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2018
Decision Date January 25, 2019
Days to Decision 42 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 130d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HHW Pessary, Vaginal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.3575
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 Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03323723 Completed Interventional Industry-sponsored

Disposable Stress Urinary Incontinence Pessary Device Study

Rinovum Subsidiary 2, LLC: Disposable Stress Urinary Incontinence Pessary Device Efficacy and Safety Study

73
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Stress Urinary Incontinence
Study design Single group
Eligibility Female only · 18 Years+ · Healthy volunteers accepted
Principal investigator Omar Felipe Duenas Garcia, MD
Sponsor Rinovum Women's Health, Inc. (industry)
Started 2017-10-16 → Primary completion 2018-05-01
Primary outcome
Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase.
Secondary outcome
Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase
View full study on ClinicalTrials.gov

Regulatory Peers - HHW Pessary, Vaginal

All 40
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K183468.
Milex™ Incontinence Dish Pessaries
K253698 · Cooper Surgical · Jan 2026
CooperSurgical Milex® Pessaries
K250438 · CooperSurgical, Inc. · Apr 2025
Cntrl+ Bladder Support Pessary
K240798 · Cntrl+, Inc. · Dec 2024
Reia pessary
K232677 · Reia, LLC · May 2024
Yoni.Fit Bladder Support
K232525 · Watkins-Conti Products, Inc. · May 2024
Uresta®
K233548 · Resilia, Inc. · Apr 2024