Cleared Special

K992694 - MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I

K992694 is an FDA 510(k) clearance for MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, manufactured by Myotronics-Noromed, Inc.. The device is a Class 2 Dental device with product code KZM cleared through the Special 510(k) pathway after a 29-day FDA review.

K992694 · Myotronics-Noromed, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
29d
Days
Class 2
Risk

K992694 is an FDA 510(k) clearance for the MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I. Classified as Device, Muscle Monitoring (product code KZM), Class II - Special Controls.

Submitted by Myotronics-Noromed, Inc. (Tukwila, US). The FDA issued a Cleared decision on September 10, 1999 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.1375 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K992694

510(k) Number K992694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1999
Decision Date September 10, 1999
Days to Decision 29 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 15
Devices cleared under the same product code (KZM) and FDA review panel - the closest regulatory comparables to K992694.
BITESTRIP
K030869 · S.L.P. , Ltd. · May 2004
BIOEMG II AND BIOJVA
K003176 · Bio-Research Associates, Inc. · Jan 2001
MODEL K7 EVALUATION DEVICE
K003287 · Myotronics-Noromed, Inc. · Nov 2000
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
K992694 · MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
Download PDF FDA Summary Myotronics-Noromed, I…