510(k) · Cleared
ClearedSedline with Frontal Psi
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 Feb 6, 2004 as substantially equivalent to K020671 (Physiometrix, Inc., 2002) after a 44-day review. Its family tree reaches back 2 generations to 2000. 60 later devices descend from it.
- Decided
- Feb 6, 2004
- Review
- 44 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001069 (2000). 60 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001069 Model 4000 Eeg Monitor with Psi (PSA4000)Physiometrix, Inc. · 2000
- 1 generation backK020671 PSA4000 Eeg Monitor with Frontal PsiPhysiometrix, Inc. · 2002
- This deviceK033999 Sedline with Frontal PsiPhysiometrix, Inc. · 2004
- Descendant · cites it directly · 59 of its ownK051874 Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose…Physiometrix, Inc. · 2005
- Descendant · 2 generations on · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- Descendant · 3 generations on · 51 of its ownK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- Descendant · 4 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- Descendant · 4 generations on · 24 of its ownK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K051874Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose SetPhysiometrix, Inc. · 2005 · cites it directly59descendants
- K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · 2 generations on58descendants
- K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014 · 3 generations on51descendants
- K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 4 generations on24descendants
- K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001069 | Model 4000 Eeg Monitor with Psi (PSA4000) | Physiometrix, Inc. | 2000 | — |
| −1 | K020671 | PSA4000 Eeg Monitor with Frontal Psi | Physiometrix, Inc. | 2002 | — |
| 0 (this device) | K033999 | Sedline with Frontal Psi | Physiometrix, Inc. | 2004 | — |
| +1 | K051874 | Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose Set | Physiometrix, Inc. | 2005 | — |
| +2 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| +3 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| +4 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| +4 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020671 | PSA4000 Eeg Monitor with Frontal PsiSummary page 3…-market notification, K020670. Physiometrix Sedline with Frontal PSI 510(k) Notiflcation page xi Predicate Device: PSA4000 EEG Monitor with Frontal PS] (K020671) Similarities: The subject device is similar to the predicate device in the following way(s): a. Both systems are EEG monitors.… | 2002 |
What descends from it? (60)
See all 601 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051874 | Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose Set | 2005 | 59 |
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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051874 (Physiometrix, Inc., 2005) has gone furthest, with 59 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 | — |
What is it indicated for?
The Sedline System is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033999: Sedline with Frontal Psi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033999
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026