Cleared Traditional

K932407 - CADWELL EASY WRITER AND EASY READER

K932407 is an FDA 510(k) clearance for CADWELL EASY WRITER AND EASY READER, 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 308-day FDA review.

K932407 · Cadwell Laboratories, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
308d
Days
Class 2
Risk

K932407 is an FDA 510(k) clearance for the CADWELL EASY WRITER AND EASY READER. 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 March 22, 1994 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K932407

510(k) Number K932407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1993
Decision Date March 22, 1994
Days to Decision 308 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 148d · This submission: 308d
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 K932407.
MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS
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K946094 · Cadwell Laboratories, Inc. · Sep 1995
NIHON KOHDEN ELECTROENCEPHALOGRAPH
K944678 · Nihon Kohden America, Inc. · May 1995
CEEGRAPH, MODIFICATION
K933233 · Bio-Logic Systems Corp. · Mar 1994
SPACELABS MEDICAL MODEL 90481 EEG MODULE
K932842 · Spacelabs Medical, Inc. · Mar 1994
E*NET NEUROMONITORING SYSTEM
K930080 · Physiometrix, Inc. · Oct 1993