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I2s Micro Implantable Systems, LLC

Country not established

Devices
1
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What I2s Micro Implantable Systems, LLC makes

I2s Micro Implantable Systems, LLC designs the Blackrock NeuroPort, a biopotential signal processing system used for neural signal acquisition and analysis, primarily in research and clinical neuroscience applications.

The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The system is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by I2s Micro Implantable Systems, LLC, initiated on 2010-03-26. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2010

    • 26 Mar 2010 Z-1619-2010 Unclassified (pre-2012) Terminated Component of cranial array may not allow sufficient tightening to maintain inserter position. Distribution: Nationwide distribution: CA, MA, NY, RI, and UT. Submission number: K042384

Frequently asked questions

How many devices does I2s Micro Implantable Systems, LLC have in the registry?

The registry currently lists 1 device for I2s Micro Implantable Systems, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list I2s Micro Implantable Systems, LLC's devices?

Among its 1 most recently registered device, I2s Micro Implantable Systems, LLC has devices listed in FDA 510(k) (1 device).

What risk classes do I2s Micro Implantable Systems, LLC's devices fall under?

Among its 1 most recently registered device, the classes recorded for I2s Micro Implantable Systems, LLC's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for I2s Micro Implantable Systems, LLC?

FDA recall records list 1 recall initiated by I2s Micro Implantable Systems, LLC, the most recent initiated on 2010-03-26. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from I2s Micro Implantable Systems, LLC in the registry?

The most recently registered devices listed for I2s Micro Implantable Systems, LLC include BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.