Cleared Traditional

K921919 - MS-100 MYO-SCANNER OR MS-100 EMG SCANNER

K921919 is an FDA 510(k) clearance for MS-100 MYO-SCANNER OR MS-100 EMG SCANNER, manufactured by Myo-Tronics, Inc.. The device is a Class 2 Dental device with product code KZM cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K921919 · Myo-Tronics, Inc. · Dental device
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Jan 1993
Decision
259d
Days
Class 2
Risk

K921919 is an FDA 510(k) clearance for the MS-100 MYO-SCANNER OR MS-100 EMG SCANNER. Classified as Device, Muscle Monitoring (product code KZM), Class II - Special Controls.

Submitted by Myo-Tronics, Inc. (Seattle, US). The FDA issued a Cleared decision on January 7, 1993 after a review of 259 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.1375 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K921919

510(k) Number K921919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1992
Decision Date January 07, 1993
Days to Decision 259 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 128d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZM Device Classification - Class 2, Special Controls

Product Code KZM Device, Muscle Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 Dental devices follow this clearance model.

Regulatory Peers - KZM Device, Muscle Monitoring

All 18
Devices cleared under the same product code (KZM) and FDA review panel - the closest regulatory comparables to K921919.
BIOPAK MEASUREMENT SYSTEM
K981563 · Bio-Research Associates, Inc. · Sep 1998
K6-1 DIAGNOSTIC SYSTEM VERSION 3.1
K944134 · Myo-Tronics, Inc. · Dec 1994
K6-I DIAGNOSTIC SYSTEM
K922456 · Myo-Tronics, Inc. · Jun 1994
BIO-EMG MODEL 800
K873947 · Bio-Research Associates, Inc. · Apr 1988
E.W.L. P-TENS/H-WAVE
K862121 · Electronic Waveform Laboratory, Inc. · Jun 1987
COMFORTRON
K862092 · M. D. Supply, Inc. · Oct 1986
K921919 · MS-100 MYO-SCANNER OR MS-100 EMG SCANNER
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