Cleared Traditional

K880901 - SONICATOR 710 (MODEL ME710)

K880901 is an FDA 510(k) clearance for SONICATOR 710 (MODEL ME710), 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 15-day FDA review.

K880901 · Mettler Electronics Corp. · Physical Medicine device
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Mar 1988
Decision
15d
Days
Class 2
Risk

K880901 is an FDA 510(k) clearance for the SONICATOR 710 (MODEL ME710). 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 March 17, 1988 after a review of 15 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

FDA 510(k) Submission Details - K880901

510(k) Number K880901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1988
Decision Date March 17, 1988
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
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 63
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K880901.
RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE
K910708 · Rich-Mar Corp. · May 1991
RICH-MAR MODEL V ULTRASOUND
K904051 · Rich-Mar Corp. · Jan 1991
SONICATOR 720 (MODEL ME720)
K883228 · Mettler Electronics Corp. · Aug 1988
MODIFIED SONICATOR 720, MODEL ME720
K880602 · Mettler Electronics Corp. · Feb 1988
SONICATOR 720 (MODEL ME720)
K873812 · Mettler Electronics Corp. · Dec 1987
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
K872393 · Henley Intl. · Jul 1987