Cleared Traditional

K946094 - CADWELL EASY AMBULATORY EEG

K946094 is an FDA 510(k) clearance for CADWELL EASY AMBULATORY EEG, manufactured by Cadwell Laboratories, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K946094 · Cadwell Laboratories, Inc. · Neurology device
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Sep 1995
Decision
272d
Days
Class 2
Risk

K946094 is an FDA 510(k) clearance for the CADWELL EASY AMBULATORY EEG. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on September 12, 1995 after a review of 272 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 Cadwell Laboratories, Inc. devices

FDA 510(k) Submission Details - K946094

510(k) Number K946094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1994
Decision Date September 12, 1995
Days to Decision 272 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
124d slower than avg
Panel avg: 148d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 103
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K946094.
MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM
K962157 · Physiometrix, Inc. · Nov 1996
CEEGRAPH TRAVELER AMBULATORY EEG RECORDER
K954954 · Bio-Logic Systems Corp. · Jan 1996
MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS
K953449 · Physiometrix, Inc. · Oct 1995
NIHON KOHDEN ELECTROENCEPHALOGRAPH
K944678 · Nihon Kohden America, Inc. · May 1995
CADWELL EASY WRITER AND EASY READER
K932407 · Cadwell Laboratories, Inc. · Mar 1994
CEEGRAPH, MODIFICATION
K933233 · Bio-Logic Systems Corp. · Mar 1994