510(k) · Cleared
ClearedBis Eeg Monitor, Model BISX4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspect Medical Systems, Inc. · OLW Index-Generating Electroencephalograph Software
Cleared on Nov 1, 2005 after an 8-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Nov 1, 2005
- Review
- 8 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK052981 Bis Eeg Monitor, Model BISX4Aspect Medical Systems, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK072286 Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 2 of its ownK131898 A Series and Q Series Patient MonitorsGuangdong Biolight Meditech Co., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK230693 BIS™ Advance Monitoring SystemCovidien, LLC · 2024
- Descendant · 3 generations on · 1 of its ownK183687 LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK254213 Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K072286Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 2007 · cites it directly8descendants
- K131898A Series and Q Series Patient MonitorsGuangdong Biolight Meditech Co., Ltd. · 2014 · 2 generations on2descendants
- K230693BIS™ Advance Monitoring SystemCovidien, LLC · 2024 · 2 generations on1descendant
- K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019 · 3 generations on1descendant
- K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052981 | Bis Eeg Monitor, Model BISX4 | Aspect Medical Systems, Inc. | 2005 | — |
| +1 | K072286 | Bis Eeg Vista Monitor System and Bisx | Aspect Medical Systems, Inc. | 2007 | 1 |
| +2 | K131898 | A Series and Q Series Patient Monitors | Guangdong Biolight Meditech Co., Ltd. | 2014 | — |
| +2 | K230693 | BIS™ Advance Monitoring System | Covidien, LLC | 2024 | — |
| +3 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | — |
| +2 | K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | Aspect Medical Systems BISx Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072286 | Bis Eeg Vista Monitor System and Bisx | 2007 | 8 |
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, K072286 (Aspect Medical Systems, Inc., 2007) has gone furthest, with 8 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 BISx4 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISx4 is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052981: Bis Eeg Monitor, Model BISX4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052981
Report an extraction error
Are you the manufacturer?
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