510(k) · Cleared
ClearedModification to Eeg Monitor with Bis, Model a-2000
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 Aug 29, 2003 as substantially equivalent to K011534 (Aspect Medical Systems, Inc., 2001) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1996. 304 later devices descend from it.
- Decided
- Aug 29, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K963644 (1996). 7 ancestors in all, the oldest K923043 (1992). 304 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 2 generations backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
- 1 generation backK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
- This deviceK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
- Descendant · cites it directly · 303 of its ownK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 274 of its ownK040183 BISXAspect Medical Systems, Inc. · 2004
- Descendant · 3 generations on · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- Descendant · 4 generations on · 251 of its ownK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- Descendant · 3 generations on · 250 of its ownK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
Showing 5 of 304 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 304 · See all- K030267Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004 · cites it directly303descendants
- K040183BISXAspect Medical Systems, Inc. · 2004 · 2 generations on274descendants
- K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · 3 generations on252descendants
- K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2004 · 4 generations on251descendants
- K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on250descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −2 | K974496 | A-2000 Eeg Monitor with Bis | Aspect Medical Systems, Inc. | 1998 | — |
| −1 | K012466 | Bis/Eeg Module | General Electric Medical Systems Information Techn | 2001 | — |
| 0 (this device) | K031694 | Modification to Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2003 | — |
| +1 | K030267 | Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2004 | — |
| +2 | K040183 | BISX | Aspect Medical Systems, Inc. | 2004 | — |
| +3 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| +4 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| +3 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 17.0 · 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? (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 |
|---|---|---|---|
| * | K011534 | Eeg Mis Monitor Model # a-2000; Bis EngineSummary page 1…Device Name Proprictary Name: A-2000™ EEG Monitor with BIS Common Name: EEG Monitor Predicate Devices Aspect Medical Systems EEG Monitor with BIS, Model A-2000 510(k) #K011534 and GE Medical Systems BIS Module 510(k) #K012466. Description The Aspect Medical Systems, Inc. A-2000 EEG BIS Monitor (hereaft… | 2001 |
| * | K012466 | Bis/Eeg ModuleSummary page 1…with BIS Common Name: EEG Monitor Predicate Devices Aspect Medical Systems EEG Monitor with BIS, Model A-2000 510(k) #K011534 and GE Medical Systems BIS Module 510(k) #K012466. Description The Aspect Medical Systems, Inc. A-2000 EEG BIS Monitor (hereafter referred to as the BIS Monitor) is an easy to u… | 2001 |
What descends from it? (304)
See all 3041 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030267 | Eeg Monitor with Bis, Model a-2000 | 2004 | 303 |
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 7 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K030267 (Aspect Medical Systems, Inc., 2004) has gone furthest, with 303 descendants of its own.
- 2 other devices also cite its predicate K011534.
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 Aspect A-2000 EEG Monitor with BIS is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS Monitor 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K031694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031694: Modification to Eeg Monitor with Bis, Model a-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031694
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