510(k) · Cleared
ClearedDigital NeuroPort Biopotential Signal Processing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackrock Microsystems · GWL Amplifier, Physiological Signal
Cleared on Feb 10, 2021 as substantially equivalent to K090957 (I2s Micro Implantable Systems, LLC, 2009) after a 190-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Feb 10, 2021
- Review
- 190 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001564 (2000). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK001564 Scan LT40 (40 Channels)Neuro Scan Labs · 2000
- 3 generations backK023536 NuampsNeuroscan · 2003
- 2 generations backK060803 G.UsbampG.Tec Medical Engineering GmbH · 2006
- 1 generation backK090957 Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009 · Recalled
- This deviceK202174 Digital NeuroPort Biopotential Signal Processing SystemBlackrock Microsystems · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001564 | Scan LT40 (40 Channels) | Neuro Scan Labs | 2000 | — |
| −3 | K023536 | Nuamps | Neuroscan | 2003 | — |
| −2 | K060803 | G.Usbamp | G.Tec Medical Engineering GmbH | 2006 | — |
| −1 | K090957 | Blackrock Neuroport Biopotential Signal Processing System | I2s Micro Implantable Systems, LLC | 2009 | 2 |
| 0 (this device) | K202174 | Digital NeuroPort Biopotential Signal Processing System | Blackrock Microsystems | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (1)
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 |
|---|---|---|---|
| * | K090957 | Blackrock Neuroport Biopotential Signal Processing SystemSummary page 4…Physiological signal amplifier (21 CFR 882.1835) II Regulatory Class GWL; GWK Product Code K090957, Blackrock NeuroPort Biopotential Signal Predicate Device Processing System Pag… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 2 other devices also cite its predicate K090957.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Digital 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202174: Digital 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/K202174
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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