Cleared Special

K030410 - ACCOUSONIC PLUS, MODEL AP-170

K030410 is an FDA 510(k) clearance for ACCOUSONIC PLUS, manufactured by Metron Medical Australia, Pty, Ltd.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Special 510(k) pathway after a 13-day FDA review.

K030410 · Metron Medical Australia, Pty, Ltd. · Physical Medicine device
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Feb 2003
Decision
13d
Days
Class 2
Risk

K030410 is an FDA 510(k) clearance for the ACCOUSONIC PLUS, MODEL AP-170. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Metron Medical Australia, Pty, Ltd. (Carrum Downs, AU). The FDA issued a Cleared decision on February 20, 2003 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K030410

510(k) Number K030410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2003
Decision Date February 20, 2003
Days to Decision 13 days
Submission Type Special
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
103d faster than avg
Panel avg: 116d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

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 77
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K030410 · ACCOUSONIC PLUS, MODEL AP-170
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