Cleared Traditional

K922456 - K6-I DIAGNOSTIC SYSTEM

K922456 is an FDA 510(k) clearance for K6-I DIAGNOSTIC SYSTEM, 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 744-day FDA review.

K922456 · Myo-Tronics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
744d
Days
Class 2
Risk

K922456 is an FDA 510(k) clearance for the K6-I DIAGNOSTIC SYSTEM. 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 June 9, 1994 after a review of 744 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K922456

510(k) Number K922456 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 26, 1992
Decision Date June 09, 1994
Days to Decision 744 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
616d slower than avg
Panel avg: 128d · This submission: 744d
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 K922456.
MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
K992694 · Myotronics-Noromed, Inc. · Sep 1999
BIOPAK MEASUREMENT SYSTEM
K981563 · Bio-Research Associates, Inc. · Sep 1998
K6-1 DIAGNOSTIC SYSTEM VERSION 3.1
K944134 · Myo-Tronics, Inc. · Dec 1994
MS-100 MYO-SCANNER OR MS-100 EMG SCANNER
K921919 · Myo-Tronics, Inc. · Jan 1993
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
K922456 · K6-I DIAGNOSTIC SYSTEM
Download PDF Myo-Tronics, Inc.