Cleared Traditional

K140780 - KEGEL SMART, KEGELSMART PEARL

K140780 is an FDA 510(k) clearance for KEGEL SMART, manufactured by Regulatory Insight, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K140780 · Regulatory Insight, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
166d
Days
Class 2
Risk

K140780 is an FDA 510(k) clearance for the KEGEL SMART, KEGELSMART PEARL. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Regulatory Insight, Inc. (Littleton, US). The FDA issued a Cleared decision on September 10, 2014 after a review of 166 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.

FDA 510(k) Submission Details - K140780

510(k) Number K140780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2014
Decision Date September 10, 2014
Days to Decision 166 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
35d slower than avg
Panel avg: 131d · This submission: 166d
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 53
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