Cleared Traditional

K001370 - ACCUSONIC PLUS, MODEL AP-100

K001370 is an FDA 510(k) clearance for ACCUSONIC PLUS, manufactured by Metron Medical Australia, Pty, Ltd.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K001370 · Metron Medical Australia, Pty, Ltd. · Physical Medicine device
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Jul 2000
Decision
77d
Days
Class 2
Risk

K001370 is an FDA 510(k) clearance for the ACCUSONIC PLUS, MODEL AP-100. 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 July 17, 2000 after a review of 77 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. 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.

FDA 510(k) Submission Details - K001370

510(k) Number K001370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2000
Decision Date July 17, 2000
Days to Decision 77 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
39d faster than avg
Panel avg: 116d · This submission: 77d
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 77
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K000604 · Naturopathic Laboratories International, Inc. · May 2000
EXONIX
K984199 · Fibra Sonics, Inc. · Feb 1999
SD-956 ULTRASOUND THERAPY
K981449 · Skylark Device Co., Ltd. · Dec 1998
K001370 · ACCUSONIC PLUS, MODEL AP-100
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