Cleared Traditional

K010702 - XUB EXTERNAL ULTRASOUND

K010702 is an FDA 510(k) clearance for XUB EXTERNAL ULTRASOUND, manufactured by Kmi Kolster Methods, Inc.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K010702 · Kmi Kolster Methods, Inc. · Physical Medicine device
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Aug 2001
Decision
154d
Days
Class 2
Risk

K010702 is an FDA 510(k) clearance for the XUB EXTERNAL ULTRASOUND. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Kmi Kolster Methods, Inc. (Anaheim, US). The FDA issued a Cleared decision on August 9, 2001 after a review of 154 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Kmi Kolster Methods, Inc. devices

FDA 510(k) Submission Details - K010702

510(k) Number K010702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2001
Decision Date August 09, 2001
Days to Decision 154 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMI Device Classification - Class 2, Special Controls

Product Code IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 52
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K010702.
ACCOUSONIC PLUS, MODEL AP-170
K030410 · Metron Medical Australia, Pty, Ltd. · Feb 2003
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
K021483 · Rich-Mar Corp. · Sep 2002
SONICATOR PLUS 930, MODEL ME 930
K013192 · Mettler Electronics Corp. · Oct 2001
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
K011955 · Metron Medical Australia, Pty, Ltd. · Jul 2001
ACCUSONIC, MODEL AS-260
K010609 · Metron Medical Australia, Pty, Ltd. · Mar 2001
SONIC MODEL SO-300
K010102 · Metron Medical Australia, Pty, Ltd. · Feb 2001