Cleared Traditional

K213913 - leva Pelvic Health System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K213913 · Renovia, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
197d
Days
Class 2
Risk

K213913 is an FDA 510(k) clearance for the leva Pelvic Health System. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Renovia, Inc. (Boston, US). The FDA issued a Cleared decision on June 30, 2022 after a review of 197 days - an extended review 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: 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 Renovia, Inc. devices

Submission Details

510(k) Number K213913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2021
Decision Date June 30, 2022
Days to Decision 197 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
67d slower than avg
Panel avg: 130d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Bold Type
Jacqueline Schmainda

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.

Clinical Evidence

ClinicalTrials.gov
NCT04027335 Unknown Interventional Industry-sponsored

Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence

Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study

31
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Fecal Incontinence
Study design Single group
Eligibility Female only · 18 Years+
Principal investigator Holly Richter, MD PhD
Sponsor Renovia, Inc. (industry)
Started 2019-08-27 → Primary completion 2020-12-21 → Completed 2021-04-30
Primary outcome
St. Mark's Incontinence Score
Secondary outcome
Change in Fecal incontinence episodes
View full study on ClinicalTrials.gov

Regulatory Peers - HIR Perineometer

All 64
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K213913.
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