Cleared Traditional

Pelvital System (K200409) - FDA 510(k) Clearance

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

K200409 · Pelvital USA, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2020
Decision
142d
Days
Class 2
Risk

K200409 is an FDA 510(k) clearance for the Pelvital System. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Pelvital USA, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 10, 2020 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1425 - 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 Pelvital USA, Inc. devices

Submission Details

510(k) Number K200409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2020
Decision Date July 10, 2020
Days to Decision 142 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
12d slower than avg
Panel avg: 130d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIR Perineometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1425
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

Hetrick Medical Device Consulting, LLC
Carrie Hetrick

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 - HIR Perineometer

All 13
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K200409.
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