Blackrock Microsystems

Salt Lake City, UT, US

Blackrock Microsystems appears in FDA device records in Salt Lake City, UT. FDA records list 4 510(k) clearances between 2009-05-28 and 2021-02-10, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 3 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 4
PMA records: 0
Recall records: 3
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Blackrock Microsystems carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

I2s Micro Implantable Systems, LLC510(k), recall

510(k) clearance history

FDA records hold 4 510(k) clearances for Blackrock Microsystems between 2009 and 2021. The busiest year on record is 2009, with 1. The most recent is 2021, with 1.

Clearances by year, as a table

510(k) clearance decisions for Blackrock Microsystems, by decision year
Year	Clearances
2009	1
2011	1
2020	1
2021	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K202174	Digital NeuroPort Biopotential Signal Processing System	GWL	Substantially Equivalent	2021-02-10
K191346	Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)	GYC	Substantially Equivalent	2020-02-14
K110010	NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM	GZL	Substantially Equivalent	2011-02-09
K090957	BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM	GWL	Substantially Equivalent	2009-05-28

Registered establishments

FDA registered establishments for Blackrock Microsystems, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3007323246	3007323246	Blackrock Microsystems	630 S Komas Dr Ste 200, Salt Lake City, UT 84108 US	2026	GWK GWL GWQ GYC GZL OLV OMC

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2764-2016	Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)	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.	Class II	2016-08-10	Terminated
Z-2763-2016	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 user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)	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.	Class II	2016-08-10	Terminated
Z-1619-2010	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 key functions. It firmly secures the Inserter Wand to prevent recoil during the NeuroPort Array insertion process, and it facilitates precision alignment of the Inserter Wand with respect to the back of the NeuroPort Array just prior to pneumatic impulse insertion.	Component of cranial array may not allow sufficient tightening to maintain inserter position.		2010-03-26	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Blackrock Microsystems edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain