Cleared Traditional

K180637 - leva Pelvic Floor Trainer (FDA 510(k) Clearance)

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

K180637 · Renovia, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
23d
Days
Class 2
Risk

K180637 is an FDA 510(k) clearance for the leva Pelvic Floor Trainer. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Renovia, Inc. (Boston, US). The FDA issued a Cleared decision on April 4, 2018 after a review of 23 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Renovia, Inc. devices

Submission Details

510(k) Number K180637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2018
Decision Date April 04, 2018
Days to Decision 23 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 130d · This submission: 23d
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 Peers - HIR Perineometer

All 64
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K180637.
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
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