Cleared Traditional

K954136 - MATRIX MICROSON 410

K954136 is an FDA 510(k) clearance for MATRIX MICROSON 410, manufactured by Matrix Biokinetics, Inc.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K954136 · Matrix Biokinetics, Inc. · Physical Medicine device
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Apr 1996
Decision
213d
Days
Class 2
Risk

K954136 is an FDA 510(k) clearance for the MATRIX MICROSON 410. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Matrix Biokinetics, Inc. (North Las Vegas, US). The FDA issued a Cleared decision on April 1, 1996 after a review of 213 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 Matrix Biokinetics, Inc. devices

FDA 510(k) Submission Details - K954136

510(k) Number K954136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1995
Decision Date April 01, 1996
Days to Decision 213 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 115d · This submission: 213d
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 54
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K954136.
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RICH-MAR US-II ULTRASOUND
K950564 · Rich-Mar Corp. · May 1995
INTELECT 222 P
K930307 · Chattanooga Group, Inc. · Jul 1993