510(k) · Cleared
ClearedBIS™ Advance pEEG Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien LP · OLW Index-Generating Electroencephalograph Software
Cleared on Aug 13, 2026 as substantially equivalent to K230693 (Covidien, LLC, 2024) after a 147-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Aug 13, 2026
- Review
- 147 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K963644 (1996). 15 ancestors in all, the oldest K923043 (1992). No later device cites it as a predicate yet.
- Root · 10 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 6 generations between
- 3 generations backK062613 Bis Eeg Monitor ViewAspect Medical Systems, Inc. · 2007
- 2 generations backK072286 Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK230693 BIS™ Advance Monitoring SystemCovidien, LLC · 2024
- This deviceK260907 BIS™ Advance pEEG ModuleCovidien LP · 2026
Show all 10 generations
- Root · 10 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 9 generations backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
- 8 generations backK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
- 7 generations backK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
- 6 generations backK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
- 5 generations backK040183 BISXAspect Medical Systems, Inc. · 2004
- 4 generations backK052362 Bis Eeg Monitor, Model a-3000Aspect Medical Systems, Inc. · 2005
- 3 generations backK062613 Bis Eeg Monitor ViewAspect Medical Systems, Inc. · 2007
- 2 generations backK072286 Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK230693 BIS™ Advance Monitoring SystemCovidien, LLC · 2024
- This deviceK260907 BIS™ Advance pEEG ModuleCovidien LP · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −9 | K974496 | A-2000 Eeg Monitor with Bis | Aspect Medical Systems, Inc. | 1998 | — |
| −8 | K012466 | Bis/Eeg Module | General Electric Medical Systems Information Techn | 2001 | — |
| −7 | K031694 | Modification to Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2003 | — |
| −6 | K030267 | Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2004 | — |
| −5 | K040183 | BISX | Aspect Medical Systems, Inc. | 2004 | — |
| −4 | K052362 | Bis Eeg Monitor, Model a-3000 | Aspect Medical Systems, Inc. | 2005 | — |
| −3 | K062613 | Bis Eeg Monitor View | Aspect Medical Systems, Inc. | 2007 | — |
| −2 | K072286 | Bis Eeg Vista Monitor System and Bisx | Aspect Medical Systems, Inc. | 2007 | 1 |
| −1 | K230693 | BIS™ Advance Monitoring System | Covidien, LLC | 2024 | — |
| 0 (this device) | K260907 | BIS™ Advance pEEG Module | Covidien LP | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 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 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 |
|---|---|---|---|
| * | K230693 | BIS™ Advance Monitoring SystemSummary page 6…Device Name: BISX™/BISX4™ Module cleared as part of BIS™ Advance Monitoring System Predicate 510(k): K230693 IV. DEVICE DESCRIPTION The BIS™ Advance pEEG Module is a finished medical device that, when connected to a compatible… | 2024 |
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 30 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
How does its category compare?
All OLW devicesOLW Index-Generating 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 · 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 BIS™ Advance pEEG Module when connected to the Host Monitor is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS™ Advance pEEG Module and all its associated parameters, is intended for use on adult and pediatric patients (4 years old and above) within a hospital or medical facility. For adult patients…
Read the full statement (217 words)
The BIS™ Advance pEEG Module when connected to the Host Monitor is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS™ Advance pEEG Module and all its associated parameters, is intended for use on adult and pediatric patients (4 years old and above) within a hospital or medical facility.
For adult patients, the BIS™ Index, one of the BIS™ Advance pEEG Module's output parameters, may be used to guide anesthetic administration of desflurane, isoflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.
The use of the BIS™ Index for monitoring may be associated with the following when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall.
For pediatric patients, ages 4 and above, the BIS™ Index, one of the BIS™ Advance pEEG Module's output parameters, may be used to guide anesthetic administration of sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.
The use of the BIS™ Index in pediatric patients, when used with sevoflurane anesthesia, has demonstrated a reduction in primary anesthetic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260907: BIS™ Advance pEEG Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260907
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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