Cleared Traditional

K961821 - ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR

K961821 is an FDA 510(k) clearance for ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR, manufactured by Aspect Medical Systems, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K961821 · Aspect Medical Systems, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
147d
Days
Class 2
Risk

K961821 is an FDA 510(k) clearance for the ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Aspect Medical Systems, Inc. (Natick, US). The FDA issued a Cleared decision on October 4, 1996 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Aspect Medical Systems, Inc. devices

FDA 510(k) Submission Details - K961821

510(k) Number K961821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1996
Decision Date October 04, 1996
Days to Decision 147 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 149d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 337
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K961821.
AQUABOND ELECTRODE
K964433 · Medibond , Ltd. · Jan 1997
EEG ELECTRODES
K962283 · Teca, Inc. · Dec 1996
M & R DISPOSABLE ELECTRODE (14200)
K963236 · M & R Mfg., Inc. · Nov 1996
EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220
K961141 · Uni-Patch, Inc. · May 1996
MODEL 1220, OR E-NET (54-62 CM)
K961609 · Physiometrix, Inc. · May 1996
MODEL 1210, MEDIUM E-NET
K960873 · Physiometrix, Inc. · Apr 1996