510(k) · Cleared
ClearedBis Engine
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 Jul 10, 2001 as substantially equivalent to K002837 (Aspect Medical Systems, Inc., 2000) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1992. 306 later devices descend from it.
- Decided
- Jul 10, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923043 (1992). 2 ancestors in all. 306 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK923043 Spectral Eeg Monitor Model A1000Aspect Medical Systems, Inc. · 1992
- This deviceK011834 Bis EngineAspect Medical Systems, Inc. · 2001
- Descendant · cites it directly · 305 of its ownK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
- Descendant · 2 generations on · 304 of its ownK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
- Descendant · 3 generations on · 303 of its ownK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
- Descendant · 4 generations on · 274 of its ownK040183 BISXAspect Medical Systems, Inc. · 2004
- Descendant · 5 generations on · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
Showing 5 of 306 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 306 · See all- K012466Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001 · cites it directly305descendants
- K031694Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003 · 2 generations on304descendants
- K030267Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004 · 3 generations on303descendants
- K040183BISXAspect Medical Systems, Inc. · 2004 · 4 generations on274descendants
- K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · 5 generations on252descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923043 | Spectral Eeg Monitor Model A1000 | Aspect Medical Systems, Inc. | 1992 | — |
| 0 (this device) | K011834 | Bis Engine | Aspect Medical Systems, Inc. | 2001 | — |
| +1 | K012466 | Bis/Eeg Module | General Electric Medical Systems Information Techn | 2001 | — |
| +2 | K031694 | Modification to Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2003 | — |
| +3 | K030267 | Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2004 | — |
| +4 | K040183 | BISX | Aspect Medical Systems, Inc. | 2004 | — |
| +5 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 8 | 0 |
| 2006 | 11 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 12 | 0 |
| 2012 | 10 | 0 |
| 2013 | 13 | 0 |
| 2014 | 12 | 0 |
| 2015 | 9 | 0 |
| 2016 | 14 | 0 |
| 2017 | 13 | 0 |
| 2018 | 16 | 0 |
| 2019 | 14 | 0 |
| 2020 | 12 | 0 |
| 2021 | 14 | 0 |
| 2022 | 21 | 0 |
| 2023 | 27 | 0 |
| 2024 | 22 | 0 |
| 2025 | 25 | 0 |
| 2026 | 16 | 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 17.1 · 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? (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 |
|---|---|---|---|
| * | K002837 | Bis EngineSummary page 1…ncephalograph (EEG) monitors and their software have been classified by the Neurological Devices Panel as Class II devices (21 CFR 882.1400) Predicate Device BIS Engine K002837, FDA cleared September 19, 2000 A-1000 EEG Monitor K923043A, FDA cleared December 3, 1992 with 4 channel amplifier (DSC-4) Devi… | 2000 |
| * | K923043 | Spectral Eeg Monitor Model A1000Summary page 1…assified by the Neurological Devices Panel as Class II devices (21 CFR 882.1400) Predicate Device BIS Engine K002837, FDA cleared September 19, 2000 A-1000 EEG Monitor K923043A, FDA cleared December 3, 1992 with 4 channel amplifier (DSC-4) Device Description The Aspect Medical Systems, Inc. BIS Engine… | 1992 |
What descends from it? (306)
See all 3061 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012466 | Bis/Eeg Module | 2001 | 305 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K012466 (General Electric Medical Systems Information Techn, 2001) has gone furthest, with 305 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?
Intended to monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room and for clinical research.
The BIS, a processed EEG variable, may be used as an aid in monitoring the effects of certain 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/K011834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011834: Bis Engine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011834
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026