Cleared Traditional

K192270 - LEva Pelvic Digital Health System

K192270 is an FDA 510(k) clearance for LEva Pelvic Digital Health System, manufactured by Renovia, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIR cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K192270 · Renovia, Inc. · Obstetrics & Gynecology device
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Nov 2019
Decision
92d
Days
Class 2
Risk

K192270 is an FDA 510(k) clearance for the LEva Pelvic Digital 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 November 22, 2019 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1425 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Renovia, Inc. devices

FDA 510(k) Submission Details - K192270

510(k) Number K192270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2019
Decision Date November 22, 2019
Days to Decision 92 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 160d · This submission: 92d
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 Obstetrics & Gynecology 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 K192270.
Flyte
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K193364 · Plus EV Holdings Dba Intimate Rose · Aug 2020
Pelvital System
K200409 · Pelvital USA, Inc. · Jul 2020
leva Pelvic Floor Trainer
K180637 · Renovia, Inc. · Apr 2018
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