Cleared Traditional

K240805 - Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (FDA 510(k) Clearance)

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

K240805 · Pelvital USA, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 2024
Decision
129d
Days
Class 2
Risk

K240805 is an FDA 510(k) clearance for the Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5). Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Pelvital USA, Inc. (Eagan, US). The FDA issued a Cleared decision on August 1, 2024 after a review of 129 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 K240805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2024
Decision Date August 01, 2024
Days to Decision 129 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
1d faster than avg
Panel avg: 130d · This submission: 129d
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

RQM+
Ming Cheng Chew

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 64
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K240805.
Pelvic Floor Exerciser (PF01)
K252748 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Apr 2026
Vaginal Tactile Ultrasound Imager
K231875 · Advanced Tactile Imaging, Inc. · Feb 2024
Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
K233362 · Pelvital USA, Inc. · Dec 2023
Perifit Care+
K231780 · X6 Innovations · Dec 2023
Perifit
K221476 · X6 Innovations · Feb 2023
leva Pelvic Health System
K213913 · Renovia, Inc. · Jun 2022