510(k) · Cleared
ClearedScan LT40 (40 Channels)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuro Scan Labs · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Nov 24, 2000 after a 189-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.
- Decided
- Nov 24, 2000
- Review
- 189 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 2 citing it directly.
- This deviceK001564 Scan LT40 (40 Channels)Neuro Scan Labs · 2000
- Descendant · cites it directly · 20 of its ownK023536 NuampsNeuroscan · 2003
- Descendant · 2 generations on · 19 of its ownK060803 G.UsbampG.Tec Medical Engineering GmbH · 2006
- Descendant · 3 generations on · 13 of its ownK090957 Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009 · Recalled
- Descendant · 3 generations on · 7 of its ownK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 4 of its ownK123255 g.HIampG.Tec Medical Engineering GmbH · 2012
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K023536NuampsNeuroscan · 2003 · cites it directly20descendants
- K060803G.UsbampG.Tec Medical Engineering GmbH · 2006 · 2 generations on19descendants
- K090957Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009 · 3 generations on13descendants
- K103140Nicolet Wireless EegCarefusion 209, Inc. · 2011 · 3 generations on7descendants
- K123255g.HIampG.Tec Medical Engineering GmbH · 2012 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001564 | Scan LT40 (40 Channels) | Neuro Scan Labs | 2000 | — |
| +1 | K023536 | Nuamps | Neuroscan | 2003 | — |
| +2 | K060803 | G.Usbamp | G.Tec Medical Engineering GmbH | 2006 | — |
| +3 | K090957 | Blackrock Neuroport Biopotential Signal Processing System | I2s Micro Implantable Systems, LLC | 2009 | 2 |
| +3 | K103140 | Nicolet Wireless Eeg | Carefusion 209, Inc. | 2011 | 1 |
| +3 | K123255 | g.HIamp | G.Tec Medical Engineering GmbH | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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 OLT? 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 OLT device
- #1 K253767 UB ERP Systemscore 14.9 · 12 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? (23)
See all 232 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, K023536 (Neuroscan, 2003) has gone furthest, with 20 descendants of its own.
How does its category compare?
All OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, 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 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
https://510kreport.com/device/K001564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001564: Scan LT40 (40 Channels).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001564
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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