Cleared Traditional

K001055 - MODEL 4300 PSARRAY EEG ELECTRODE SET

K001055 is an FDA 510(k) clearance for MODEL 4300 PSARRAY EEG ELECTRODE SET, manufactured by Physiometrix, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K001055 · Physiometrix, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
38d
Days
Class 2
Risk

K001055 is an FDA 510(k) clearance for the MODEL 4300 PSARRAY EEG ELECTRODE SET. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Physiometrix, Inc. (North Billerica, US). The FDA issued a Cleared decision on May 11, 2000 after a review of 38 days - a notably fast clearance cycle.

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: 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 Physiometrix, Inc. devices

FDA 510(k) Submission Details - K001055

510(k) Number K001055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2000
Decision Date May 11, 2000
Days to Decision 38 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
110d faster than avg
Panel avg: 148d · This submission: 38d
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 194
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K001055.
KM-10 TENS ELECTRODE
K000870 · Katecho, Inc. · Nov 2000
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
K001980 · Aspect Medical Systems, Inc. · Sep 2000
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
ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR
K961821 · Aspect Medical Systems, Inc. · Oct 1996