Cleared Traditional

K844707 - QUANTUM 84

K844707 is an FDA 510(k) clearance for QUANTUM 84, 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 169-day FDA review.

K844707 · Cadwell Laboratories, Inc. · Neurology device
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May 1985
Decision
169d
Days
Class 2
Risk

K844707 is an FDA 510(k) clearance for the QUANTUM 84. 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 May 21, 1985 after a review of 169 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 - K844707

510(k) Number K844707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1984
Decision Date May 21, 1985
Days to Decision 169 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
21d slower than avg
Panel avg: 148d · This submission: 169d
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 K844707.
TRAVELER LT
K862690 · Bio-Logic Systems Corp. · Nov 1986
NEUROPACK 8, MEE-4108
K851300 · Nihon Kohden America, Inc. · Jun 1985
BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM
K844992 · Bio-Logic Systems Corp. · Jun 1985
EVOKED POTENTIAL SYS
K842543 · Bio-Logic Systems Corp. · Nov 1984
COMPACT FOUR
K831896 · Nicolet Biomedical Instruments · Jul 1983
CADWELL 8400
K830771 · Cadwell Laboratories, Inc. · Apr 1983