Cleared Traditional

K851397 - SONICATOR 705 MODEL ME 705

K851397 is the FDA 510(k) clearance for SONICATOR 705 MODEL ME 705 by Mettler Electronics Corp.. It is a Class 2 Physical Medicine device (product code IMI) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K851397 · Mettler Electronics Corp. · Physical Medicine device
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Jul 1985
Decision
84d
Days
Class 2
Risk

K851397 is an FDA 510(k) clearance for the SONICATOR 705 MODEL ME 705. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on July 2, 1985 after a review of 84 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 Mettler Electronics Corp. devices

Submission Details

510(k) Number K851397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date July 02, 1985
Days to Decision 84 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
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 25
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K851397.
RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE
K910708 · Rich-Mar Corp. · May 1991
RICH-MAR MODEL V ULTRASOUND
K904051 · Rich-Mar Corp. · Jan 1991
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
K872393 · Henley Intl. · Jul 1987
US 610
K844036 · Rich-Mar Corp. · Nov 1984
INTELECT 205 PORTABLE ULTRASOUND UNIT
K841445 · Chattanooga Group, Inc. · May 1984
INTELECT 200 THERAPEUTIC ULTRASOUND
K841446 · Chattanooga Group, Inc. · May 1984