Cleared Traditional

K010088 - REAL PATIENT AMBULATORY EEG

K010088 is the FDA 510(k) clearance for REAL PATIENT AMBULATORY EEG by Excel Tech. , Ltd.. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K010088 · Excel Tech. , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
74d
Days
Class 2
Risk

K010088 is an FDA 510(k) clearance for the REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED). Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on March 26, 2001 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 Excel Tech. , Ltd. devices

Submission Details

510(k) Number K010088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2001
Decision Date March 26, 2001
Days to Decision 74 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
74d faster than avg
Panel avg: 148d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 88
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K010088.
EMU128S, MODEL EX-NW-128S
K040360 · Excel Tech. , Ltd. · Mar 2004
96 CHANNEL EEG HEADBOX MODEL EMU96
K021599 · Excel Tech. , Ltd. · Aug 2002
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
K010086 · Excel Tech. , Ltd. · Apr 2001
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
K010089 · Excel Tech. , Ltd. · Mar 2001
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
K010084 · Excel Tech. , Ltd. · Mar 2001
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
K010150 · Excel Tech. , Ltd. · Feb 2001