510(k) · Cleared
ClearedPascall Sensor Unit (PSU1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pascall Systems, Inc. · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Aug 19, 2026 as substantially equivalent to K213299 (Pascall Systems, Inc., 2022) and 1 other predicate after a 233-day review. Its family tree reaches back 10 generations to 1988.
- Decided
- Aug 19, 2026
- Review
- 233 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K875179 (1988). 89 ancestors in all, the oldest K791580 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 6 generations between
- 3 generations backK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- 2 generations backK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- 1 generation backK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
- This deviceK254213 Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 9 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 8 generations backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- 7 generations backK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- 6 generations backK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- 5 generations backK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- 4 generations backK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- 3 generations backK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- 2 generations backK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- 1 generation backK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
- This deviceK254213 Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −9 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −8 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| −7 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| −6 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| −5 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| −4 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| −3 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| −2 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
| −1 | K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022 | — |
| 0 (this device) | K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 3 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K213299 | Wireless EEG SystemSummary page 5…ification Reg.: 882.1400 Primary Product Code: OLT Additional Product Code: OMC, ORT, GXY Predicate Device: Pascall Wireless EEG System (K213299) Secondary Predicate Covidien/BIS EEG VISTA Monitor System (K072286) Device:… | 2022 |
| * | K072286 | Bis Eeg Vista Monitor System and BisxSummary page 5…ct Code: OMC, ORT, GXY Predicate Device: Pascall Wireless EEG System (K213299) Secondary Predicate Covidien/BIS EEG VISTA Monitor System (K072286) Device: 002_0001 Device Description: The Pascall Wireles… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 8 companies; a new generation was cleared every 3.2 years on median.
- 10 of the 89 ancestors have a recall of any class.
- 1 other device also cites its predicate K213299.
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. 2026, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Pascall Systems, Inc. Wireless EEG System is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display. The Pascall Systems, Inc. Wireless EEG System is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and…
Read the full statement (163 words)
The Pascall Systems, Inc. Wireless EEG System is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display. The Pascall Systems, Inc. Wireless EEG System is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis. The Pascall Systems, Inc. Wireless EEG System is intended for use in a hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as a physician’s office, laboratory, clinic, or in outpatient settings.
The Pascall Systems, Inc. Wireless EEG System is indicated for use on patients 18 years of age or older and is to be used under the direction and interpretation of a licensed medical professional. The Pascall Systems, Inc. Wireless EEG System does not provide any diagnostic conclusion about the patient's condition.
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/K254213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254213: Pascall Sensor Unit (PSU1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254213
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026