Cleared Traditional

K962457 - TWO-CHANNEL PREAMPLIFIER

K962457 is an FDA 510(k) clearance for TWO-CHANNEL PREAMPLIFIER, manufactured by Cadwell Laboratories, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K962457 · Cadwell Laboratories, Inc. · Neurology device
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Jan 1997
Decision
202d
Days
Class 2
Risk

K962457 is an FDA 510(k) clearance for the TWO-CHANNEL PREAMPLIFIER. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on January 13, 1997 after a review of 202 days - an extended review cycle.

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 Cadwell Laboratories, Inc. devices

FDA 510(k) Submission Details - K962457

510(k) Number K962457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1996
Decision Date January 13, 1997
Days to Decision 202 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
54d slower than avg
Panel avg: 148d · This submission: 202d
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 61
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K962457.
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
K992313 · Excel Tech. , Ltd. · Aug 1999
GALILEO EVOKED POTENTIALRE
K963662 · Biosound, Inc. · Feb 1997
FOUR-CHANNEL PREAMPLIFIER
K962455 · Cadwell Laboratories, Inc. · Jan 1997
CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
K962458 · Cadwell Laboratories, Inc. · Jan 1997
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
K950208 · Nihon Kohden America, Inc. · May 1995
DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)
K931923 · Dantec Medical, Inc. · Nov 1993