Cleared Traditional

K193364 - Intimate Rose Kegel Exercise System (FDA 510(k) Clearance)

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

K193364 · Plus EV Holdings Dba Intimate Rose · Obstetrics & Gynecology device
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Aug 2020
Decision
264d
Days
Class 2
Risk

K193364 is an FDA 510(k) clearance for the Intimate Rose Kegel Exercise System. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Plus EV Holdings Dba Intimate Rose (North Kansas City, US). The FDA issued a Cleared decision on August 24, 2020 after a review of 264 days - an extended review cycle.

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 Plus EV Holdings Dba Intimate Rose devices

Submission Details

510(k) Number K193364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2019
Decision Date August 24, 2020
Days to Decision 264 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 160d · This submission: 264d
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 Obstetrics & Gynecology 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 K193364.
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Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
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Perifit
K221476 · X6 Innovations · Feb 2023