510(k) · Cleared
ClearedA-2000 Eeg Monitor with Bis
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 Feb 6, 1998 as substantially equivalent to K963644 (Aspect Medical Systems, Inc., 1996) after a 70-day review. Its family tree reaches back 1 generation to 1996. 337 later devices descend from it.
- Decided
- Feb 6, 1998
- Review
- 70 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963644 (1996). 337 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- This deviceK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
- 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 337 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 337 · 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 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| 0 (this device) | K974496 | A-2000 Eeg Monitor with Bis | Aspect Medical Systems, Inc. | 1998 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 9 | 0 |
| 2006 | 11 | 0 |
| 2007 | 8 | 0 |
| 2008 | 12 | 0 |
| 2009 | 7 | 0 |
| 2010 | 11 | 0 |
| 2011 | 12 | 0 |
| 2012 | 11 | 0 |
| 2013 | 14 | 0 |
| 2014 | 13 | 0 |
| 2015 | 11 | 0 |
| 2016 | 15 | 0 |
| 2017 | 14 | 0 |
| 2018 | 17 | 0 |
| 2019 | 16 | 0 |
| 2020 | 15 | 0 |
| 2021 | 14 | 0 |
| 2022 | 22 | 0 |
| 2023 | 27 | 0 |
| 2024 | 23 | 0 |
| 2025 | 27 | 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? (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 |
|---|---|---|---|
| * | K963644 | A-1000 Eeg Monitor and a-1050 Eeg MonitorSummary page 1…ied by the Neurological Devices Panel as Class II devices (21 CFR 882.1400) Predicate Device Aspect Medical Systems EEG Monitor, Model A-1050 with BIS ™. This 510(k), #K963644, received FDA clearance October 8, 1996. Device Description The Aspect A-2000 Monitor dimensions are 7 inches wide x 6.8 inches… | 1996 |
| † | K952347 | A-1050 Eeg Monitor | 1996 |
What descends from it? (337)
See all 3376 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 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/K974496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974496: A-2000 Eeg Monitor with Bis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974496
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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