Cleared Traditional

K900482 - SOFTWARE & HARDWARE ADDITION TO SENTINE...

K900482 is an FDA 510(k) clearance for SOFTWARE & HARDWARE ADDITION TO SENTINE..., manufactured by Axon Systems, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K900482 · Axon Systems, Inc. · Neurology device
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Jun 1990
Decision
139d
Days
Class 2
Risk

K900482 is an FDA 510(k) clearance for the SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Axon Systems, Inc. (Hauppauge, US). The FDA issued a Cleared decision on June 20, 1990 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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.

View all Axon Systems, Inc. devices

FDA 510(k) Submission Details - K900482

510(k) Number K900482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1990
Decision Date June 20, 1990
Days to Decision 139 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 148d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 55
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K900482.
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
K912685 · Nihon Kohden America, Inc. · Feb 1992
HIGH SPEED MAGNETIC STIMULATOR
K905059 · Cadwell Laboratories, Inc. · Sep 1991
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
K903731 · Teca, Inc. · Feb 1991
MEM-7102
K890274 · Nihon Kohden America, Inc. · May 1989
TECA/MEDELEC 'CONCEPT' P420
K884870 · Teca, Inc. · Feb 1989
CADWELL EXCEL
K880088 · Cadwell Laboratories, Inc. · May 1988