Cleared Traditional

K981563 - BIOPAK MEASUREMENT SYSTEM

K981563 is an FDA 510(k) clearance for BIOPAK MEASUREMENT SYSTEM, manufactured by Bio-Research Associates, Inc.. The device is a Class 2 Dental device with product code KZM cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K981563 · Bio-Research Associates, Inc. · Dental device
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Sep 1998
Decision
137d
Days
Class 2
Risk

K981563 is an FDA 510(k) clearance for the BIOPAK MEASUREMENT SYSTEM. Classified as Device, Muscle Monitoring (product code KZM), Class II - Special Controls.

Submitted by Bio-Research Associates, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 15, 1998 after a review of 137 days - within the typical 510(k) review window.

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 - K981563

510(k) Number K981563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1998
Decision Date September 15, 1998
Days to Decision 137 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 128d · This submission: 137d
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 K981563.
BIOEMG II AND BIOJVA
K003176 · Bio-Research Associates, Inc. · Jan 2001
MODEL K7 EVALUATION DEVICE
K003287 · Myotronics-Noromed, Inc. · Nov 2000
MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
K992694 · Myotronics-Noromed, Inc. · Sep 1999
K6-1 DIAGNOSTIC SYSTEM VERSION 3.1
K944134 · Myo-Tronics, Inc. · Dec 1994
K6-I DIAGNOSTIC SYSTEM
K922456 · Myo-Tronics, Inc. · Jun 1994
MS-100 MYO-SCANNER OR MS-100 EMG SCANNER
K921919 · Myo-Tronics, Inc. · Jan 1993
K981563 · BIOPAK MEASUREMENT SYSTEM
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