Cleared Special

K202174 - Digital NeuroPort Biopotential Signal Processing System (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K202174 · Blackrock Microsystems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
190d
Days
Class 2
Risk

K202174 is an FDA 510(k) clearance for the Digital NeuroPort Biopotential Signal Processing System. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Blackrock Microsystems (Salt Lake City, US). The FDA issued a Cleared decision on February 10, 2021 after a review of 190 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Blackrock Microsystems devices

Submission Details

510(k) Number K202174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2020
Decision Date February 10, 2021
Days to Decision 190 days
Submission Type Special
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
42d slower than avg
Panel avg: 148d · This submission: 190d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 52
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