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Blackrock Microsystems

Last updated September 17, 2026

Information

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
XactTrode Patient Cable	028907	FDA UDI	Class II	Active
Blackrock NeuroPort Biopotential Signal Processing System	7698	FDA UDI	Class II	Active
Blackrock NeuroPort Biopotential Signal Processing System	10411	FDA UDI	Class II	Active
Blackrock NeuroPort Biopotential Signal Processing System	10098	FDA UDI	Class II	Active
NeuroPort Inserter Assembly	4469	FDA UDI	Class II	Active
XactGrid	028938	FDA UDI	Class II	Active
XactTrode Patient Cable	028917	FDA UDI	Class II	Active
XactTrode Patient Cable	028920	FDA UDI	Class II	Active
NeuroPlex E128	12889	FDA UDI	Class II	Active
XactTrode Patient Cable	028897	FDA UDI	Class II	Active
XactStrip	028941	FDA UDI	Class II	Active
XactStrip	028933	FDA UDI	Class II	Active
XactStrip	027671	FDA UDI	Class II	Active
XactStrip	027685	FDA UDI	Class II	Active
XactTrode Patient Cable	028909	FDA UDI	Class II	Active
XactStrip	027683	FDA UDI	Class II	Active
Neuroport Cortical Microelectrode Array System	K110010	FDA 510(k)	Class II	Active
Digital NeuroPort Biopotential Signal Processing System	K202174	FDA 510(k)	Class II	Active
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)	K191346	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 10, 2016	Z-2764-2016	—	terminated	Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts.
Aug 10, 2016	Z-2763-2016	—	terminated	Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts.