Cleared Traditional

K984052 - SYNERGY IOM SYSTEM

K984052 is an FDA 510(k) clearance for SYNERGY IOM SYSTEM, manufactured by Oxford Instruments Medical Systems. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K984052 · Oxford Instruments Medical Systems · Neurology device
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May 1999
Decision
185d
Days
Class 2
Risk

K984052 is an FDA 510(k) clearance for the SYNERGY IOM SYSTEM. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Oxford Instruments Medical Systems (Crofton, US). The FDA issued a Cleared decision on May 17, 1999 after a review of 185 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K984052

510(k) Number K984052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1998
Decision Date May 17, 1999
Days to Decision 185 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 149d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
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 Neurology devices follow this clearance model.

Regulatory Peers - IKN Electromyograph, Diagnostic

All 60
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K984052.
MA-300 ELECTROMYOGRAPHY SYSTEM
K000220 · Motion Lab Systems, Inc. · Feb 2000
JE 2000
K993878 · Jack'S Electrodes · Feb 2000
CERSR ELECTROMYOGRAPHY SYSTEM
K990766 · Paraspinal Diagnostic Corp. · Aug 1999
TOENNIES NEUROSCREEN SYSTEM
K972419 · Erich Jaeger, Inc. · Apr 1998
MLS ELECTROMYOGRAPHIC PREAMPLIFIER
K974385 · Motion Lab Systems, Inc. · Feb 1998
ADVANTAGE EMG SYSTEM, MODEL #A100
K974010 · Advantage Medical Division of Cme Telemetrix · Jan 1998
K984052 · SYNERGY IOM SYSTEM
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