Cleared Traditional

K883228 - SONICATOR 720 (MODEL ME720)

K883228 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 17-day FDA review.

K883228 · Mettler Electronics Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
17d
Days
Class 2
Risk

K883228 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 August 18, 1988 after a review of 17 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 - K883228

510(k) Number K883228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1988
Decision Date August 18, 1988
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
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 K883228.
RICH-MAR MODEL 25 ULTRASOUND
K912202 · Rich-Mar Corp. · Sep 1991
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 710 (MODEL ME710)
K880901 · Mettler Electronics Corp. · Mar 1988
MODIFIED SONICATOR 720, MODEL ME720
K880602 · Mettler Electronics Corp. · Feb 1988
SONICATOR 720 (MODEL ME720)
K873812 · Mettler Electronics Corp. · Dec 1987