510(k) · Cleared
ClearedSynamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps (129-256 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 Jul 11, 2000 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 11, 2000
- Review
- 76 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK001324 Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps…Neuro Scan Labs · 2000
- Descendant · cites it directly · 4 of its ownK023771 SYNAMPS2Neuroscan · 2003
- Descendant · 2 generations on · 2 of its ownK081151 Compumedics NeuvoCompumedics USA, Ltd. · 2008
- Descendant · 3 generations on · 1 of its ownK093223 Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited · 2010
- Descendant · 4 generations on · 0 of its ownK230073 OktiCompumedics Limited · 2023
- Descendant · 2 generations on · 0 of its ownK042364 Panbus Digital Eeg & Sleep Acquisition DevicesLamont Medical, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K023771SYNAMPS2Neuroscan · 2003 · cites it directly4descendants
- K081151Compumedics NeuvoCompumedics USA, Ltd. · 2008 · 2 generations on2descendants
- K093223Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited · 2010 · 3 generations on1descendant
- K230073OktiCompumedics Limited · 2023 · 4 generations on0descendants
- K042364Panbus Digital Eeg & Sleep Acquisition DevicesLamont Medical, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001324 | Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps (129-256… | Neuro Scan Labs | 2000 | — |
| +1 | K023771 | SYNAMPS2 | Neuroscan | 2003 | — |
| +2 | K081151 | Compumedics Neuvo | Compumedics USA, Ltd. | 2008 | — |
| +3 | K093223 | Compumedics Grael System, Models: Grael, Grael Ecg | Compumedics Limited | 2010 | — |
| +4 | K230073 | Okti | Compumedics Limited | 2023 | — |
| +2 | K042364 | Panbus Digital Eeg & Sleep Acquisition Devices | Lamont Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2023 | 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023771 | SYNAMPS2 | 2003 | 4 |
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, K023771 (Neuroscan, 2003) has gone furthest, with 4 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/K001324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001324: Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps (129-256 Channels).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001324
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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