510(k) · Cleared
Recalled · 2005Compumedics E-Series Eeg System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumedics Neuro Science Pty, Ltd. · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Mar 13, 2000 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 570 devices in its family, counting itself, has a Class I recall. 569 later devices descend from it. It has been recalled once.
- Decided
- Mar 13, 2000
- Review
- 63 days
- Class
- Class II
- Product code
- OLT
- Recalls
- 1
- Predicates
- 0
569 later devices descend from it, 4 citing it directly. 1 of the 570 devices in this family, counting this one, has a Class I recall.
- This deviceK000068 Compumedics E-Series Eeg SystemCompumedics Neuro Science Pty, Ltd. · 2000
- Descendant · cites it directly · 471 of its ownK021807 Grass-Telefactor AS40 Amplifier SystemGrass Instrument Co. · 2002
- Descendant · 2 generations on · 460 of its ownK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- Descendant · 3 generations on · 450 of its ownK061113 OrthomonAxon Systems, Inc. · 2006
- Descendant · 3 generations on · 426 of its ownK061639 Eclipse TCD Neurovascular Workstation; Elclipse Neurological…Axon Systems, Inc. · 2006
- Descendant · 4 generations on · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
Showing 5 of 569 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub9 generations on · 2021
Most influential descendants
Showing 5 of 569 · See all- K021807Grass-Telefactor AS40 Amplifier SystemGrass Instrument Co. · 2002 · cites it directly471descendants
- K050798Eclipse Neurological WorkstationAxon Systems, Inc. · 2005 · 2 generations on460descendants
- K061113OrthomonAxon Systems, Inc. · 2006 · 3 generations on450descendants
- K061639Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…Axon Systems, Inc. · 2006 · 3 generations on426descendants
- K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · 4 generations on418descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000068 | Compumedics E-Series Eeg System | Compumedics Neuro Science Pty, Ltd. | 2000 | — |
| +1 | K021807 | Grass-Telefactor AS40 Amplifier System | Grass Instrument Co. | 2002 | — |
| +2 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| +3 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| +3 | K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with… | Axon Systems, Inc. | 2006 | — |
| +4 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 9 | 0 |
| 2014 | 5 | 0 |
| 2015 | 12 | 0 |
| 2016 | 11 | 0 |
| 2017 | 24 | 0 |
| 2018 | 25 | 0 |
| 2019 | 36 | 0 |
| 2020 | 27 | 0 |
| 2021 | 45 | 1 |
| 2022 | 58 | 0 |
| 2023 | 74 | 0 |
| 2024 | 70 | 0 |
| 2025 | 76 | 0 |
| 2026 | 68 | 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.
1 device in this family has a Class I recall. 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? (569)
See all 5694 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 24, 2005 | Not classified | Z-0652-05 | Other | Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021807 (Grass Instrument Co., 2002) has gone furthest, with 471 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/K000068 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000068: Compumedics E-Series Eeg System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000068
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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