Cleared Traditional

K870815 - KONTRON E.E.G. MONITOR

K870815 is an FDA 510(k) clearance for KONTRON E.E.G. MONITOR, manufactured by Kontron Instruments, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K870815 · Kontron Instruments, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
335d
Days
Class 2
Risk

K870815 is an FDA 510(k) clearance for the KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on February 1, 1988 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K870815

510(k) Number K870815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date February 01, 1988
Days to Decision 335 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
187d slower than avg
Panel avg: 148d · This submission: 335d
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 93
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K870815.
CADWELL FREEDOM EEG DEVICE
K894276 · Cadwell Laboratories, Inc. · Sep 1989
TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS
K890881 · Teca, Inc. · Mar 1989
AE-800PA EEG MODULE
K884537 · Nihon Kohden America, Inc. · Dec 1988
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
K874796 · Nihon Kohden America, Inc. · Jan 1988
AMBULATORY EEG PLAYBACK
K872183 · Cadwell Laboratories, Inc. · Jul 1987
MODEL 5000 AMBULATORY MONITORING SYSTEM
K871500 · Oxford Medilog, Inc. · Jul 1987