# K090957: Blackrock Neuroport Biopotential Signal Processing System

- Pathway: 510(k) (Abbreviated)
- Applicant: I2s Micro Implantable Systems, LLC
- Decided: May 28, 2009 after 52 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001564 (2000). 6 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042626: Neuroport Neural Signal Processor (NSP) System, Cyberkinetics, Inc. (2005) Summary page 1.
- K060803: G.Usbamp, G.Tec Medical Engineering GmbH (2006) Summary page 1.
- K040113: Sandman SD20 Amplifier, Eb Neuro S.P.A. (2004) Summary page 1.

## Most influential descendants
- K103140: Nicolet Wireless Eeg (2011), 7 descendants of its own
- K122196: Cervello Bio-Potential Signal Acquistion System Product Family (2013), 3 descendants of its own
- K170441: ElectroTek (2017), 1 descendant of its own
- K162681: Enobio Wireless EEG (2017), 1 descendant of its own
- K151600: R-40 EEG  Amplifier (2015), 1 descendant of its own

## Recalls of this device
- Aug 10, 2016 · Class II · Z-2763-2016: 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 incorrect
- Aug 10, 2016 · Class II · Z-2764-2016: 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 incorrect

## Indications for use
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).

Source page: https://510kreport.com/device/K090957
Methodology: https://510kreport.com/methodology