510(k) · Cleared
ClearedModel 4000 Eeg Monitor with Psi (PSA4000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physiometrix, Inc. · OLW Index-Generating Electroencephalograph Software
Cleared on Jun 30, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 62 later devices descend from it.
- Decided
- Jun 30, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 0
62 later devices descend from it, 1 citing it directly.
- This deviceK001069 Model 4000 Eeg Monitor with Psi (PSA4000)Physiometrix, Inc. · 2000
- Descendant · cites it directly · 61 of its ownK020671 PSA4000 Eeg Monitor with Frontal PsiPhysiometrix, Inc. · 2002
- Descendant · 2 generations on · 60 of its ownK033999 Sedline with Frontal PsiPhysiometrix, Inc. · 2004
- Descendant · 3 generations on · 59 of its ownK051874 Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose…Physiometrix, Inc. · 2005
- Descendant · 4 generations on · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- Descendant · 5 generations on · 51 of its ownK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K020671PSA4000 Eeg Monitor with Frontal PsiPhysiometrix, Inc. · 2002 · cites it directly61descendants
- K033999Sedline with Frontal PsiPhysiometrix, Inc. · 2004 · 2 generations on60descendants
- K051874Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose SetPhysiometrix, Inc. · 2005 · 3 generations on59descendants
- K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · 4 generations on58descendants
- K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014 · 5 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001069 | Model 4000 Eeg Monitor with Psi (PSA4000) | Physiometrix, Inc. | 2000 | — |
| +1 | K020671 | PSA4000 Eeg Monitor with Frontal Psi | Physiometrix, Inc. | 2002 | — |
| +2 | K033999 | Sedline with Frontal Psi | Physiometrix, Inc. | 2004 | — |
| +3 | K051874 | Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose Set | Physiometrix, Inc. | 2005 | — |
| +4 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| +5 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 9 | 0 |
| 2023 | 6 | 0 |
| 2024 | 10 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 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 OLW? 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 OLW device
- #1 K260880 SedLine Sedation Monitorscore 17.0 · 19 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? (62)
See all 621 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020671 | PSA4000 Eeg Monitor with Frontal Psi | 2002 | 61 |
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, K020671 (Physiometrix, Inc., 2002) has gone furthest, with 61 descendants of its own.
How does its category compare?
All OLW devicesOLW Index-Generating Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OLW
105in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLW
No recall names OLW since 2007.
Adverse event reports per year · OLW
73in 2025
MAUDE reports naming product code OLW, 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 | 3 | 105 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 93 |
| 2025 | 0 | — | 0 | 73 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K001069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001069: Model 4000 Eeg Monitor with Psi (PSA4000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001069
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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