Cleared Traditional

K802296 - MINGOGRAF EEG10 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K802296 · Siemens Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
14d
Days
Class 2
Risk

K802296 is an FDA 510(k) clearance for the MINGOGRAF EEG10. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Siemens Corp. (Walker, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 14 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 Siemens Corp. devices

Submission Details

510(k) Number K802296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1980
Decision Date October 03, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 148d · This submission: 14d
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 187
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K802296.
New Wave System
K260455 · Zeto, Inc. · Mar 2026
Flexset System
K233403 · Zeto, Inc. · Apr 2024
Neuronaute Plus
K231366 · Bioserenity Sas · Nov 2023
Q21
K221959 · Neurofield, Inc. · Aug 2023
SPARK Scan
K231457 · Spark Neuro, Inc. · Aug 2023
Cumulus Functional Neurophysiology Platform
K221963 · Cumulus Neuroscience Limited · Apr 2023