Cleared Traditional

K873812 - SONICATOR 720 (MODEL ME720)

K873812 is an FDA 510(k) clearance for SONICATOR 720 (MODEL ME720), manufactured by Mettler Electronics Corp.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K873812 · Mettler Electronics Corp. · Physical Medicine device
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Dec 1987
Decision
83d
Days
Class 2
Risk

K873812 is an FDA 510(k) clearance for the SONICATOR 720 (MODEL ME720). 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 December 10, 1987 after a review of 83 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 - K873812

510(k) Number K873812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1987
Decision Date December 10, 1987
Days to Decision 83 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 116d · This submission: 83d
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 88
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K873812.
ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER
K875381 · Ford Laboratories, Inc. · May 1988
SONICATOR 710 (MODEL ME710)
K880901 · Mettler Electronics Corp. · Mar 1988
MODIFIED SONICATOR 720, MODEL ME720
K880602 · Mettler Electronics Corp. · Feb 1988
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
K872393 · Henley Intl. · Jul 1987
MEDCO-SONIC NQ-2000
K860099 · Medco Products, Co., Inc. · Apr 1986
SONOMED 4
K851937 · Robert Bosch Corp. · Jul 1985
K873812 · SONICATOR 720 (MODEL ME720)
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