510(k) · Cleared
Recalled · Class II · 2024Seer Home
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seer Medical Pty, Ltd. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jun 16, 2022 as substantially equivalent to K170441 (Mobilemedtek, 2017) after a 288-day review. Its family tree reaches back 6 generations to 2000. It has been recalled once.
- Decided
- Jun 16, 2022
- Review
- 288 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001564 (2000). 18 ancestors in all, the oldest K946094 (1995). 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 backK170441 ElectroTekMobilemedtek · 2017 · Recalled
- This deviceK212788 Seer HomeSeer Medical Pty, Ltd. · 2022
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 | K170441 | ElectroTek | Mobilemedtek | 2017 | 2 |
| 0 (this device) | K212788 | Seer Home | Seer Medical Pty, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2015 | 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 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 |
|---|---|---|---|
| * | K170441 | ElectroTekSummary page 4…Louisville, KY 40206 Device Type: Full-Montage Standard Electroencephalograph 510(k) Number: K170441 Product Code: GWQ Device Class: II Regulation numbers:… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2024 | Class II | Z-3143-2024 | Under Investigation by firm | During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 18 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. 2022, 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 electroencephalographic system Seer Home is intended to acquire, display, and store the electro-physiological signals of the patient's brain obtained by placing electrodes on the patient scalp.
The Seer Home is intended to be used for such studies as electroencephalograph (EEG) and video EEG recording to aid in diagnosis of neurological disorders. The Seer Home does not draw any diagnostic conclusions.
Seer Home is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
Seer Home is only to be used under the direction and supervision of a physician or EEG technologist or clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212788 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212788: Seer Home.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212788
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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