Cleared Traditional

K854030 - WRIST ACTIGRAPH

K854030 is an FDA 510(k) clearance for WRIST ACTIGRAPH, manufactured by Ambulatory Monitoring, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K854030 · Ambulatory Monitoring, Inc. · Neurology device
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Jun 1986
Decision
267d
Days
Class 2
Risk

K854030 is an FDA 510(k) clearance for the WRIST ACTIGRAPH. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Ambulatory Monitoring, Inc. (Ardsley, US). The FDA issued a Cleared decision on June 25, 1986 after a review of 267 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 Ambulatory Monitoring, Inc. devices

FDA 510(k) Submission Details - K854030

510(k) Number K854030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1985
Decision Date June 25, 1986
Days to Decision 267 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 148d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 97
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K854030.
TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH
K863749 · Teca, Inc. · Oct 1986
NEUROFAX 7310 SERIES (EEG)
K854663 · Nihon Kohden America, Inc. · Aug 1986
MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
K860456 · Oxford Medilog, Inc. · Aug 1986
DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER
K854268 · Del Mar Avionics · Mar 1986
BUSHEL OFF-HEAD PREAMPLIFIER
K850418 · Oxford Medilog, Inc. · Jun 1985
TECA MONTAGE II
K851232 · Teca, Inc. · Jun 1985