Cleared Special

K233362 - Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (FDA 510(k) Clearance)

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

K233362 · Pelvital USA, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 2023
Decision
88d
Days
Class 2
Risk

K233362 is an FDA 510(k) clearance for the Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0). Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Pelvital USA, Inc. (Eagan, US). The FDA issued a Cleared decision on December 29, 2023 after a review of 88 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 K233362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2023
Decision Date December 29, 2023
Days to Decision 88 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
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 Peers - HIR Perineometer

All 64
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K233362.
Pelvic Floor Exerciser (PF01)
K252748 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Apr 2026
Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
K240805 · Pelvital USA, Inc. · Aug 2024
Vaginal Tactile Ultrasound Imager
K231875 · Advanced Tactile Imaging, Inc. · Feb 2024
Perifit Care+
K231780 · X6 Innovations · Dec 2023
Perifit
K221476 · X6 Innovations · Feb 2023
leva Pelvic Health System
K213913 · Renovia, Inc. · Jun 2022