Cleared Special

K003287 - MODEL K7 EVALUATION DEVICE

K003287 is an FDA 510(k) clearance for MODEL K7 EVALUATION DEVICE, 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 17-day FDA review.

K003287 · Myotronics-Noromed, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
17d
Days
Class 2
Risk

K003287 is an FDA 510(k) clearance for the MODEL K7 EVALUATION DEVICE. 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 November 6, 2000 after a review of 17 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 - K003287

510(k) Number K003287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2000
Decision Date November 06, 2000
Days to Decision 17 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
111d faster than avg
Panel avg: 128d · This submission: 17d
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 K003287.
DOLOTENS DENTAL TM 1
K043373 · Neuromuscular Technologies, Inc. · Sep 2005
BITESTRIP
K030869 · S.L.P. , Ltd. · May 2004
BIOEMG II AND BIOJVA
K003176 · Bio-Research Associates, Inc. · Jan 2001
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
K003287 · MODEL K7 EVALUATION DEVICE
Download PDF FDA Summary Myotronics-Noromed, I…