Cleared Traditional

K231780 - Perifit Care+ (FDA 510(k) Clearance)

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

K231780 · X6 Innovations · Gastroenterology & Urology device
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Dec 2023
Decision
187d
Days
Class 2
Risk

K231780 is an FDA 510(k) clearance for the Perifit Care+. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by X6 Innovations (Paris, FR). The FDA issued a Cleared decision on December 20, 2023 after a review of 187 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 X6 Innovations devices

Submission Details

510(k) Number K231780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2023
Decision Date December 20, 2023
Days to Decision 187 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
57d slower than avg
Panel avg: 130d · This submission: 187d
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 Consultant

Hogan Lovells US LLP
Lina Kontos

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.

Regulatory Peers - HIR Perineometer

All 64
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K231780.
Pelvic Floor Exerciser (PF01)
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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
K221476 · X6 Innovations · Feb 2023
leva Pelvic Health System
K213913 · Renovia, Inc. · Jun 2022