510(k) · Cleared
ClearedMizar, Basis BE, Sandman Digital
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eb Neuro S.P.A. · GWL Amplifier, Physiological Signal
Cleared on Jan 5, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 116 later devices descend from it.
- Decided
- Jan 5, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 0
116 later devices descend from it, 5 citing it directly.
- This deviceK003154 Mizar, Basis BE, Sandman DigitalEb Neuro S.P.A. · 2001
- Descendant · cites it directly · 48 of its ownK031202 Medipalm-20Braebon Medical Corp. · 2003
- Descendant · cites it directly · 43 of its ownK071230 Apnea Risk Evaluation System (Ares), Model 600Advanced Brain Monitoring, Inc. · 2007
- Descendant · 2 generations on · 41 of its ownK110705 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · 2 generations on · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 40 of its ownK111194 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
Showing 5 of 116 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 116 · See all- K031202Medipalm-20Braebon Medical Corp. · 2003 · cites it directly48descendants
- K071230Apnea Risk Evaluation System (Ares), Model 600Advanced Brain Monitoring, Inc. · 2007 · cites it directly43descendants
- K110705Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · 2 generations on41descendants
- K073682Embletta GoldEmbla Systems, Inc. · 2008 · 2 generations on41descendants
- K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · 3 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003154 | Mizar, Basis BE, Sandman Digital | Eb Neuro S.P.A. | 2001 | — |
| +1 | K031202 | Medipalm-20 | Braebon Medical Corp. | 2003 | — |
| +1 | K071230 | Apnea Risk Evaluation System (Ares), Model 600 | Advanced Brain Monitoring, Inc. | 2007 | — |
| +2 | K110705 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +2 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| +3 | K111194 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 9 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 11 | 0 |
| 2023 | 9 | 0 |
| 2024 | 8 | 0 |
| 2025 | 11 | 0 |
| 2026 | 12 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (116)
See all 1165 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031202 (Braebon Medical Corp., 2003) has gone furthest, with 48 descendants of its own.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K003154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003154: Mizar, Basis BE, Sandman Digital.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003154
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026