Cleared Traditional

K180637 - leva Pelvic Floor Trainer

K180637 is an FDA 510(k) clearance for leva Pelvic Floor Trainer, manufactured by Renovia, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 23-day FDA review.

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

FDA 510(k) Submission Details - K180637

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
Combination Product No
PCCP Authorized No
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.

HIR Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K180637.
Intimate Rose Kegel Exercise System
K193364 · Plus EV Holdings Dba Intimate Rose · Aug 2020
Pelvital System
K200409 · Pelvital USA, Inc. · Jul 2020
LEva Pelvic Digital Health System
K192270 · Renovia, Inc. · Nov 2019
INCARE PELVIC FLOOR THERAPY SYSTEM
K013612 · Hollister, Inc. · Mar 2002
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
K013653 · Hollister, Inc. · Mar 2002
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
K970145 · Biosearch Medical Products, Inc. · Aug 1997