Cleared Special

Flyte (K210764) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210764 · Pelvital USA, Inc. · Gastroenterology & Urology device
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Apr 2021
Decision
29d
Days
Class 2
Risk

K210764 is an FDA 510(k) clearance for the Flyte. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Pelvital USA, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 13, 2021 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1425 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pelvital USA, Inc. devices

Submission Details

510(k) Number K210764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2021
Decision Date April 13, 2021
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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

Winegar Consulting, Inc.
Mike Winegar

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 K210764.
leva Pelvic Health System
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Pelvital System
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LEva Pelvic Digital Health System
K192270 · Renovia, Inc. · Nov 2019