Cleared Traditional

K860801 - MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)

K860801 is an FDA 510(k) clearance for MODEL 8400 W/MODIFICATIONS (SPECTRUM 32), manufactured by Cadwell Laboratories, Inc.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K860801 · Cadwell Laboratories, Inc. · Neurology device
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Nov 1986
Decision
259d
Days
Class 2
Risk

K860801 is an FDA 510(k) clearance for the MODEL 8400 W/MODIFICATIONS (SPECTRUM 32). Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on November 18, 1986 after a review of 259 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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 - K860801

510(k) Number K860801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date November 18, 1986
Days to Decision 259 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
111d slower than avg
Panel avg: 148d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 20
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K860801.
TECA/MEDELEC MISTRAL
K880593 · Teca, Inc. · Apr 1988
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
K874136 · Bio-Logic Systems Corp. · Mar 1988
TECA NEUROPTO WITH OS-5 STIMULATOR
K861069 · Teca, Inc. · Jan 1987
MODIFIED BRAIN ATLAS III
K854362 · Bio-Logic Systems Corp. · Apr 1986
L.E.D. GOGGLES, MODEL 580-LEDGOG
K852533 · Bio-Logic Systems Corp. · Dec 1985
SLS 3500 LED VISUAL STIMULATOR
K842381 · Nihon Kohden America, Inc. · Nov 1984