Cleared Traditional

K240798 - Cntrl+ Bladder Support Pessary (FDA 510(k) Clearance)

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

K240798 · Cntrl+, Inc. · Gastroenterology & Urology device
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Dec 2024
Decision
270d
Days
Class 2
Risk

K240798 is an FDA 510(k) clearance for the Cntrl+ Bladder Support Pessary. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Cntrl+, Inc. (Cornwall, CA). The FDA issued a Cleared decision on December 17, 2024 after a review of 270 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cntrl+, Inc. devices

Submission Details

510(k) Number K240798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2024
Decision Date December 17, 2024
Days to Decision 270 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
140d slower than avg
Panel avg: 130d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Avania Cro Canada, Inc.
Charusheila Ramkumar

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HHW Pessary, Vaginal

All 40
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K240798.
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Yoni.Fit Bladder Support
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Uresta®
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