Cleared Traditional

K001370 - ACCUSONIC PLUS, MODEL AP-100 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001370 · Metron Medical Australia, Pty, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Metron Medical Australia, Pty, Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 88
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K001370.
Ultrasound Stimulator
K240788 · Jkh Health Co., Ltd. · Jun 2025
Sonopuls 190
K230472 · Enraf-Nonius, B.V. · Oct 2023
ManaSport+
K222098 · Manamed, Inc. · Mar 2023
ManaSport
K210284 · Manamed, Inc. · Apr 2022
Sonomed IV, Sonomed V
K202788 · Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto · Dec 2021
UltraTENS
K142976 · Shenzhen Dongdixin Technology Co., Ltd. · Aug 2015