Cleared Traditional

K860457 - ELECTROCARDIOGRAPH CONTINUOUS MONITOR

K860457 is an FDA 510(k) clearance for ELECTROCARDIOGRAPH CONTINUOUS MONITOR, manufactured by Oxford Medilog, Inc.. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K860457 · Oxford Medilog, Inc. · Neurology device
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Apr 1986
Decision
84d
Days
Class 2
Risk

K860457 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPH CONTINUOUS MONITOR. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Oxford Medilog, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 30, 1986 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - 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 Oxford Medilog, Inc. devices

FDA 510(k) Submission Details - K860457

510(k) Number K860457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1986
Decision Date April 30, 1986
Days to Decision 84 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
64d faster than avg
Panel avg: 148d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWN Device Classification - Class 2, Special Controls

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 - GWN Nystagmograph

All 16
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K860457.
I-Portal Neuro Otologic Test Center
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TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL
K842886 · Teca, Inc. · Dec 1984
NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH
K822268 · Kelleher Corp. · Jan 1983