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
Download Printable Device Report (PDF)
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
1d faster than avg
Panel avg: 148d · 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 184
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K961821.
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
K002734 · Aspect Medical Systems, Inc. · Sep 2000
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K994330 · Aspect Medical Systems, Inc. · Jan 2000
EEG ELECTRODES
K962283 · Teca, Inc. · Dec 1996
DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123
K944314 · Bio-Logic Systems Corp. · Jan 1996
NEUROLOGICAL DIAGNOSTIC DEVICES
K943449 · Henley Intl. · Nov 1995
MEDI-TRAC EEG ELECTRODE
K950782 · Graphic Controls Corp. · Jun 1995