510(k) Report

510(k) · Cleared

Cleared

PSA4000 Eeg Monitor with Frontal Psi

K020671510(k) SpecialCleared Oct 4, 2002217-day reviewClass II21 CFR 882.1400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Physiometrix, Inc. · OLW Index-Generating Electroencephalograph Software

Cleared on Oct 4, 2002 as substantially equivalent to K001069 (Physiometrix, Inc., 2000) after a 217-day review. Its family tree reaches back 1 generation to 2000. 61 later devices descend from it.

Decided
Oct 4, 2002
Review
217 days
Class
Class II
Product code
OLW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001069 (2000). 61 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 1 descendant cleared2014: 2 descendants cleared2018: 2 descendants cleared2016: 2 descendants cleared2015: 1 descendant cleared2023: 6 descendants cleared2022: 9 descendants cleared2019: 5 descendants cleared2017: 2 descendants cleared2026: 6 descendants cleared2025: 8 descendants cleared2020: 5 descendants cleared2024: 10 descendants cleared2021: 1 descendant clearedK001069 · Model 4000 Eeg Monitor with Psi (PSA4000) · Physiometrix, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 5 descendants6 generations forward: 6 descendants7 generations forward: 12 descendants8 generations forward: 21 descendants9 generations forward: 11 descendants10 generations forward: 1 descendant K001069 · Model 4000 Eeg Monitor with Psi (PSA4000) · Physiometrix, Inc. · 20000+5+10
  1. Root · 1 generation backK001069 Model 4000 Eeg Monitor with Psi (PSA4000)Physiometrix, Inc. · 2000
  2. This deviceK020671 PSA4000 Eeg Monitor with Frontal PsiPhysiometrix, Inc. · 2002
  3. Descendant · cites it directly · 60 of its ownK033999 Sedline with Frontal PsiPhysiometrix, Inc. · 2004
  4. Descendant · 2 generations on · 59 of its ownK051874 Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose…Physiometrix, Inc. · 2005
  5. Descendant · 3 generations on · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
  6. Descendant · 4 generations on · 51 of its ownK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
  7. Descendant · 5 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12014: 22015: 12016: 22017: 22018: 22019: 52020: 52021: 12022: 92023: 62024: 102025: 82026: 6
2004high 10 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 61 · See all
  • K033999Sedline with Frontal PsiPhysiometrix, Inc. · 2004 · cites it directly60descendants
  • K051874Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose SetPhysiometrix, Inc. · 2005 · 2 generations on59descendants
  • K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · 3 generations on58descendants
  • K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014 · 4 generations on51descendants
  • K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 5 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001069Model 4000 Eeg Monitor with Psi (PSA4000)Physiometrix, Inc.2000—
0 (this device)K020671PSA4000 Eeg Monitor with Frontal PsiPhysiometrix, Inc.2002—
+1K033999Sedline with Frontal PsiPhysiometrix, Inc.2004—
+2K051874Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose SetPhysiometrix, Inc.2005—
+3K140188Masimo Root Monitoring SystemMasimo Corporation2014—
+4K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation2014—
+5K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
201420
201510
201620
201720
201820
201950
202050
202110
202290
202360
2024100
202580
202660
FIG. 1 — Lineage of K020671, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260880 SedLine Sedation Monitorscore 17.0 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K001069Model 4000 Eeg Monitor with Psi (PSA4000)
Summary page 2
…n a PCMCIA card is detected on start up of the menilor, data will be automatically stored on the PCMCIA Hard Disk Drive. Predicate Device: PSA4000 EEG Monitor with PSI (K001069) Similarities: The subject device is similar to the predicate device in the following ways: a. Both systems are EEG monitors. b.…
Physiometrix, Inc.2000—

What descends from it? (61)

See all 61

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033999Sedline with Frontal PsiPhysiometrix, Inc.200460

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?

  • Its one ancestor has no recall.
  • Of its descendants, K033999 (Physiometrix, Inc., 2004) has gone furthest, with 60 descendants of its own.

How does its category compare?

All OLW devices

OLW Index-Generating Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OLW

1in 2024

2007: 32008: 22015: 12018: 12021: 12022: 12023: 12024: 12026 (partial year): 2
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLW

105in 2007

2007: 105 days median
2007high 105 (2007)2026

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

2017: 32018: 32019: 62020: 152021: 152022: 272023: 182024: 932025: 73
2007high 93 (2024) · low 0 (2007)2025

MAUDE reports naming product code OLW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007310500
20082—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20170—03
20181—03
20190—06
20200—015
20211—015
20221—027
20231—018
20241—093
20250—073
20262—0—

What is it indicated for?

The PSA4000 EEG Monitor with Frontal PSI 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 anesthelic

agents.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Physiometrix, Inc.

22 FDA decisions under this applicant name. See the company

  • K051874Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose SetPhysiometrix, Inc. · 2005
  • K033999Sedline with Frontal PsiPhysiometrix, Inc. · 2004
  • K020670Model 4310 PSARRAY2 Eeg ElectrodePhysiometrix, Inc. · 2002
  • K001069Model 4000 Eeg Monitor with Psi (PSA4000)Physiometrix, Inc. · 2000
  • K001055Model 4300 Psarray Eeg Electrode SetPhysiometrix, Inc. · 2000

Recent decisions in OLW

The OLW category page

  • K260907BIS™ Advance pEEG ModuleCovidien LP · 2026
  • K260880SedLine Sedation MonitorMasimo Corporation · 2026
  • K230693BIS™ Advance Monitoring SystemCovidien, LLC · 2024
  • K213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics, Ltd. · 2023
  • K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation · 2022

https://510kreport.com/device/K020671 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020671: PSA4000 Eeg Monitor 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/K020671

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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