Cleared Abbreviated

K042554 - AUTO THERM 390, MODEL ME 390

K042554 is an FDA 510(k) clearance for AUTO THERM 390, manufactured by Mettler Electronics Corp.. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K042554

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Standards-based clearance path.

IMJ Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K042554.
SW-THERM
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BIOFUSIONARY BEBE
K121123 · Rocky Mountain Biosystems, Inc. · Mar 2014
BTL ELITE
K120093 · BTL Industries, Inc. · Oct 2012
AUTO*THERM 395, MODEL ME 395
K022458 · Mettler Electronics Corp. · Sep 2002
MEGAPULSE II
K973732 · Pti · Jan 1998
ULTRATHERM (908)
K964083 · Sie-Med, Inc. · Apr 1997