510(k) · Cleared
ClearedTrackit T4 EEG Amplifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifelines, Ltd. · GWQ Full-Montage Standard Electroencephalograph
Cleared on May 4, 2018 as substantially equivalent to K151600 (Lifelines, Ltd., 2015) after a 280-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- May 4, 2018
- Review
- 280 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001564 (2000). 15 ancestors in all, the oldest K964280 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK001564 Scan LT40 (40 Channels)Neuro Scan Labs · 2000
- 5 generations backK023536 NuampsNeuroscan · 2003
- 4 generations backK060803 G.UsbampG.Tec Medical Engineering GmbH · 2006
- 3 generations backK090957 Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009 · Recalled
- 2 generations backK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011 · Recalled
- 1 generation backK151600 R-40 EEG AmplifierLifelines, Ltd. · 2015
- This deviceK172271 Trackit T4 EEG AmplifierLifelines, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001564 | Scan LT40 (40 Channels) | Neuro Scan Labs | 2000 | — |
| −5 | K023536 | Nuamps | Neuroscan | 2003 | — |
| −4 | K060803 | G.Usbamp | G.Tec Medical Engineering GmbH | 2006 | — |
| −3 | K090957 | Blackrock Neuroport Biopotential Signal Processing System | I2s Micro Implantable Systems, LLC | 2009 | 2 |
| −2 | K103140 | Nicolet Wireless Eeg | Carefusion 209, Inc. | 2011 | 1 |
| −1 | K151600 | R-40 EEG Amplifier | Lifelines, Ltd. | 2015 | — |
| 0 (this device) | K172271 | Trackit T4 EEG Amplifier | Lifelines, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 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 GWQ? 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 GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 10 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 |
|---|---|---|---|
| * | K151600 | R-40 EEG AmplifierSummary page 4…Product 510(k) # Lifelines, Ltd. R40 EEG Amplifier K151600 DEVICE DESCRIPTION The Trackit T4 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab… | 2015 |
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 18 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 15 ancestors have a recall of any class.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, 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 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Trackit T4 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172271 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172271: Trackit T4 EEG Amplifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172271
Report an extraction error
Are you the manufacturer?
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