Cleared Traditional

K960732 - HYDROSPOT EEG ELECTRODE MODEL 1501

K960732 is an FDA 510(k) clearance for HYDROSPOT EEG ELECTRODE MODEL 1501, 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 53-day FDA review.

K960732 · Physiometrix, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
53d
Days
Class 2
Risk

K960732 is an FDA 510(k) clearance for the HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Physiometrix, Inc. (N. Billerica, US). The FDA issued a Cleared decision on April 15, 1996 after a review of 53 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 - K960732

510(k) Number K960732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1996
Decision Date April 15, 1996
Days to Decision 53 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
95d faster than avg
Panel avg: 148d · This submission: 53d
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 K960732.
MODEL 1220, OR E-NET (54-62 CM)
K961609 · Physiometrix, Inc. · May 1996
MODEL 1210, MEDIUM E-NET
K960873 · Physiometrix, Inc. · Apr 1996
MODEL 1240, SMALL E NET
K960885 · Physiometrix, Inc. · Apr 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