Cleared Traditional

K860128 - MODAC-XXXX INTENSIVE MONITORING OF EEG

K860128 is the FDA 510(k) clearance for MODAC-XXXX INTENSIVE MONITORING OF EEG by Grass-Telefactor Product Group. It is a Class 2 Neurology device (product code GYE) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K860128 · Grass-Telefactor Product Group · Neurology device
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Mar 1986
Decision
72d
Days
Class 2
Risk

K860128 is an FDA 510(k) clearance for the MODAC-XXXX INTENSIVE MONITORING OF EEG. Classified as Encephalogram Telemetry System (product code GYE), Class II - Special Controls.

Submitted by Grass-Telefactor Product Group (W. Conshohocken, US). The FDA issued a Cleared decision on March 27, 1986 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1855 - 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 Grass-Telefactor Product Group devices

Submission Details

510(k) Number K860128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1986
Decision Date March 27, 1986
Days to Decision 72 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 148d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYE Encephalogram Telemetry System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1855
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 - GYE Encephalogram Telemetry System

Devices cleared under the same product code (GYE) and FDA review panel - the closest regulatory comparables to K860128.
MODEL 219 TELEMETRY SYSTEM
K895895 · Mennen Medical, Inc. · Feb 1990
BMS-2000 MOBILE EEG SYSTEM
K891405 · Buckman Co., Inc. · Aug 1989
TELEMETRY SYSTEM XMT-1 & REC-1
K792371 · Burdick Corp. · Jan 1980
CMS 6000
K792380 · Physio-Control Corp. · Jan 1980
G.E. TELEMETRY MONITORING
K761259 · General Electric Co. · Dec 1976