Facility

Blackrock Microsystems

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007323246
Establishment type	Manufacture Medical Device
Location	630 S Komas Dr Ste 200 Salt Lake City, UT, US 84108
Registration status	Active · expires 2026
Parent company	Blackrock Microsystems (owner-operator 10027942)
Brand names	Blackrock NeuroPort Biopotential signal Processing System

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Amplifier, Physiological Signal
Product code GWL (opens in a new tab) · Class II · Neurology · 21 CFR 882.1835

Recalls & enforcement

Class IITerminated2016-08-10
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.

FDA inspections (1)

NAI2016-10-26
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Blackrock Microsystems

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Blackrock Microsystems (FEI 3007323246) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007323246-blackrock-microsystems/

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