510(k) · Cleared
Recalled · Class II · 2016Blackrock Neuroport Biopotential Signal Processing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I2s Micro Implantable Systems, LLC · GWL Amplifier, Physiological Signal
Cleared on May 28, 2009 as substantially equivalent to K042626 (Cyberkinetics, Inc., 2005) and 2 other predicates after a 52-day review. Its family tree reaches back 3 generations to 2000. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- May 28, 2009
- Review
- 52 days
- Class
- Class II
- Product code
- GWL
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K001564 (2000). 6 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK001564 Scan LT40 (40 Channels)Neuro Scan Labs · 2000
- 2 generations backK023536 NuampsNeuroscan · 2003
- 1 generation backK060803 G.UsbampG.Tec Medical Engineering GmbH · 2006
- This deviceK090957 Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009
- Descendant · cites it directly · 7 of its ownK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011 · Recalled
- Descendant · cites it directly · 3 of its ownK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
- Descendant · 2 generations on · 1 of its ownK170441 ElectroTekMobilemedtek · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK162681 Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017
- Descendant · 2 generations on · 1 of its ownK151600 R-40 EEG AmplifierLifelines, Ltd. · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K103140Nicolet Wireless EegCarefusion 209, Inc. · 2011 · cites it directly7descendants
- K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013 · cites it directly3descendants
- K170441ElectroTekMobilemedtek · 2017 · 2 generations on1descendant
- K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017 · 2 generations on1descendant
- K151600R-40 EEG AmplifierLifelines, Ltd. · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001564 | Scan LT40 (40 Channels) | Neuro Scan Labs | 2000 | — |
| −2 | K023536 | Nuamps | Neuroscan | 2003 | — |
| −1 | K060803 | G.Usbamp | G.Tec Medical Engineering GmbH | 2006 | — |
| 0 (this device) | K090957 | Blackrock Neuroport Biopotential Signal Processing System | I2s Micro Implantable Systems, LLC | 2009 | — |
| +1 | K103140 | Nicolet Wireless Eeg | Carefusion 209, Inc. | 2011 | 1 |
| +1 | K122196 | Cervello Bio-Potential Signal Acquistion System Product Family | Blackrock Neuromed, LLC | 2013 | — |
| +2 | K170441 | ElectroTek | Mobilemedtek | 2017 | 2 |
| +2 | K162681 | Enobio Wireless EEG | Neuroelectrics Barcelona S.L.U. | 2017 | — |
| +2 | K151600 | R-40 EEG Amplifier | Lifelines, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWL device
- #1 K232210 X-trodes System Mscore 10.4 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042626 | Neuroport Neural Signal Processor (NSP) SystemSummary page 1…CFR 882.1845 Physiological Signal Conditioners, Product Code: GWK Predicate Devices: 510(k) Number: K042626 Trade Name: NeuroPortTM Neural Signal Processing (NSP) System 5 10(k) N… | 2005 |
| * | K060803 | G.UsbampSummary page 1…510(k) Number: K042626 Trade Name: NeuroPortTM Neural Signal Processing (NSP) System 5 10(k) Number: K060803 Trade Name: g.USBamp 510(k) Number: K040113… | 2006 |
| * | K040113 | Sandman SD20 AmplifierSummary page 1…sing (NSP) System 5 10(k) Number: K060803 Trade Name: g.USBamp 510(k) Number: K040113 Trade Name: Sandman SD20 Amplifier 1.0 Description of Device The Blackrock Neu… | 2004 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2016 | Class II | Z-2763-2016 | Labeling False and Misleading | 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. |
| Aug 10, 2016 | Class II | Z-2764-2016 | Labeling False and Misleading | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K103140 (Carefusion 209, Inc., 2011) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K042626.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWL
133in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWL
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWL
1in 2018
MAUDE reports naming product code GWL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 133 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090957: Blackrock Neuroport Biopotential Signal Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090957
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026