Cleared Traditional

K944615 - A620 EEG

K944615 is an FDA 510(k) clearance for A620 EEG, manufactured by Stoelting Co.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K944615 · Stoelting Co. · Neurology device
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Sep 1995
Decision
363d
Days
Class 2
Risk

K944615 is an FDA 510(k) clearance for the A620 EEG. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Stoelting Co. (Wood Dale, US). The FDA issued a Cleared decision on September 18, 1995 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 Stoelting Co. devices

FDA 510(k) Submission Details - K944615

510(k) Number K944615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1994
Decision Date September 18, 1995
Days to Decision 363 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 148d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 43
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K944615.
AT53 DUAL CHANNEL EMG
K952797 · Stoelting Co. · Apr 1996
DIGITAL CONDUCTANCE METER
K924313 · The Jayms Co. · Mar 1996
ORALSENSOR
K953257 · Cycura Corp. · Feb 1996
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K945826 · Medical Device Inspection Co., Inc. · Aug 1995
MYOTRAC2
K915858 · Thought Technology , Ltd. · Sep 1992
MYOTRAC/S, MYODAC/S
K915859 · Thought Technology , Ltd. · Sep 1992