Cleared Traditional

K905059 - HIGH SPEED MAGNETIC STIMULATOR

K905059 is an FDA 510(k) clearance for HIGH SPEED MAGNETIC STIMULATOR, 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 314-day FDA review.

K905059 · Cadwell Laboratories, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
314d
Days
Class 2
Risk

K905059 is an FDA 510(k) clearance for the HIGH SPEED MAGNETIC STIMULATOR. 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 September 18, 1991 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 - K905059

510(k) Number K905059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1990
Decision Date September 18, 1991
Days to Decision 314 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 148d · This submission: 314d
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 K905059.
CADWELL SIERRA
K924723 · Cadwell Laboratories, Inc. · Mar 1993
DANTEC EVOLUTION
K924127 · Dantec Medical, Inc. · Mar 1993
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
K912685 · Nihon Kohden America, Inc. · Feb 1992
DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)
K902607 · Dantec Medical, Inc. · May 1991
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
K903731 · Teca, Inc. · Feb 1991
CANTATA EMG/EVOKED RESPONSE SYSTEM
K896567 · Dantec Medical, Inc. · Feb 1990