Cleared Abbreviated

K042554 - AUTO THERM 390

K042554 is the FDA 510(k) clearance for AUTO THERM 390 by Mettler Electronics Corp.. It is a Class 2 Physical Medicine device (product code IMJ) cleared through the Abbreviated 510(k) pathway after a 18-day FDA review.

K042554 · Mettler Electronics Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
18d
Days
Class 2
Risk

K042554 is an FDA 510(k) clearance for the AUTO THERM 390, MODEL ME 390. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on October 8, 2004 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Mettler Electronics Corp. devices

Submission Details

510(k) Number K042554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2004
Decision Date October 08, 2004
Days to Decision 18 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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 - IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

All 13
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K042554.
BTL-703
K182363 · BTL Industries, Inc. · Jan 2019
ViaTherm BOOST
K173300 · Viatherm Therapeutics, LLC · May 2018
BTL ELITE
K120093 · BTL Industries, Inc. · Oct 2012
MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS
K864653 · Rich-Mar Corp. · Dec 1986
THE BIO-TEK UW-II
K862932 · Bio-Tek Instruments, Inc. · Sep 1986
RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC
K862468 · Rich-Mar Corp. · Jul 1986