Data / Medical devices / United States / Blackrock Microsystems
Blackrock Microsystems: FDA-registered device maker in Salt Lake City, UT, United States, 9 510(k) clearances
Blackrock Microsystems is registered with the FDA (registration 3007323246) in Salt Lake City, UT, United States. It lists 7 device types. The FDA files 9 510(k) clearances under its listings, the newest dated February 10, 2021. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007323246
- Address
- 630 S Komas Dr Ste 200, Salt Lake City, UT, United States, 84108
- Owner or operator
- Blackrock Microsystems (10027942)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 16, 2008
- Registered through
- 2026
- Brand names listed
- Blackrock NeuroPort Biopotential signal Processing System, Cervello, Digital NeuroPort Biopotential Signal Processing System, Neural Signal Monitoring System, NeuroPort Array, NeuroPort Electrode, NeuroPort Electrode (SIROF), NeuroPort Neural Signal Processing and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier, Physiological Signal | GWL | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Conditioner, Signal, Physiological | GWK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode, Cortical | GYC | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Depth | GZL | 2 | Manufacturer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 2 | Manufacturer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 10, 2021 | K202174 | Digital NeuroPort Biopotential Signal Processing System | GWL | Substantially Equivalent | Blackrock Microsystems | accessdata.fda.gov |
| February 14, 2020 | K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | GYC | Substantially Equivalent | Blackrock Microsystems | accessdata.fda.gov |
| May 2, 2013 | K122196 | CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY | GWQ | Substantially Equivalent | Blackrock Neuromed, LLC | accessdata.fda.gov |
| February 9, 2011 | K110010 | NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM | GZL | Substantially Equivalent | Blackrock Microsystems, Inc. | accessdata.fda.gov |
| May 28, 2009 | K090957 | BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM | GWL | Substantially Equivalent | I2s Micro Implantable Systems, LLC | accessdata.fda.gov |
| August 3, 2007 | K070272 | NEUROPORT ELECTRODE | GZL | Substantially Equivalent | Cyberkinetics Neurotechnology Systems, Inc. | accessdata.fda.gov |
| March 28, 2006 | K060523 | NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM | OMC | Substantially Equivalent | Cyberkinetics, Inc. | accessdata.fda.gov |
| March 29, 2005 | K042384 | NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM | GZL | Substantially Equivalent | Cyberkinetics, Inc. (Cki) | accessdata.fda.gov |
| March 28, 2005 | K042626 | NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM | GWQ | Substantially Equivalent | Cyberkinetics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 10, 2016 | 74893 | Class II | Terminated | Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from us | 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. | accessdata.fda.gov |
| March 26, 2010 | 55304 | Not yet classified | Terminated | Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake City, UT. Intended use: The Inserter Wand Holder serves two | Component of cranial array may not allow sufficient tightening to maintain inserter position. | accessdata.fda.gov |
Compare with other makers
- All makers of Amplifier, Physiological Signal
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Standard Polysomnograph With Electroencephalograph
- All makers of Reduced- Montage Standard Electroencephalograph
- All makers of Electrode, Depth
Updated February 10, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.