Cleared Traditional

K862410 - MILEX KEGEL PERINEAL EXERCISER

K862410 is the FDA 510(k) clearance for MILEX KEGEL PERINEAL EXERCISER by Milex Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code HIR) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K862410 · Milex Products, Inc. · Gastroenterology & Urology device
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Jul 1986
Decision
36d
Days
Class 2
Risk

K862410 is an FDA 510(k) clearance for the MILEX KEGEL PERINEAL EXERCISER. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Milex Products, Inc. (Chicago, US). The FDA issued a Cleared decision on July 31, 1986 after a review of 36 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 Milex Products, Inc. devices

Submission Details

510(k) Number K862410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1986
Decision Date July 31, 1986
Days to Decision 36 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 130d · This submission: 36d
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.