Cleared Traditional

K863956 - MACULOSCOPE(TM)

K863956 is the FDA 510(k) clearance for MACULOSCOPE(TM) by Doran Instruments, Inc.. It is a Class 2 Neurology device (product code GWE) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K863956 · Doran Instruments, Inc. · Neurology device
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Nov 1986
Decision
34d
Days
Class 2
Risk

K863956 is an FDA 510(k) clearance for the MACULOSCOPE(TM). Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Doran Instruments, Inc. (Littleton, US). The FDA issued a Cleared decision on November 13, 1986 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Doran Instruments, Inc. devices

Submission Details

510(k) Number K863956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1986
Decision Date November 13, 1986
Days to Decision 34 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 148d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K863956.
KILOWIN
K971214 · Cadwell Laboratories, Inc. · Jun 1998
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
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MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
K860801 · Cadwell Laboratories, Inc. · Nov 1986
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