510(k) · Cleared
ClearedEeg 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 Jan 15, 2004 as substantially equivalent to K011534 (Aspect Medical Systems, Inc., 2001) and 1 other predicate after a 353-day review. Its family tree reaches back 4 generations to 1996. 303 later devices descend from it.
- Decided
- Jan 15, 2004
- Review
- 353 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K963644 (1996). 8 ancestors in all, the oldest K923043 (1992). 303 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 3 generations backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
- 2 generations backK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
- 1 generation backK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
- This deviceK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
- Descendant · cites it directly · 274 of its ownK040183 BISXAspect Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- Descendant · 3 generations on · 251 of its ownK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- Descendant · 2 generations on · 250 of its ownK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 2 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
Showing 5 of 303 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 303 · See all- K040183BISXAspect Medical Systems, Inc. · 2004 · cites it directly274descendants
- K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · 2 generations on252descendants
- K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2004 · 3 generations on251descendants
- K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on250descendants
- K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on249descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −3 | K974496 | A-2000 Eeg Monitor with Bis | Aspect Medical Systems, Inc. | 1998 | — |
| −2 | K012466 | Bis/Eeg Module | General Electric Medical Systems Information Techn | 2001 | — |
| −1 | K031694 | Modification to Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K030267 | Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2004 | — |
| +1 | K040183 | BISX | Aspect Medical Systems, Inc. | 2004 | — |
| +2 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| +3 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| +2 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +2 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | 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 | 3 | 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…n classified by the Ncurological Devices Panel as Class Il devices (21 CFR 882.1400) Predicate Devices Aspect Medical Systems A-2000 EEG Monitor with BIS This 510(k), #K011534, received FDA clearance 6/15/01 Aspect Medical Systems A-2000 EEG Monitor with BIS This 510(k), #K031694, received FDA clearance… | 2001 |
| * | K031694 | Modification to Eeg Monitor with Bis, Model a-2000 Cleared while this submission was under review Summary page 1…spect Medical Systems A-2000 EEG Monitor with BIS This 510(k), #K011534, received FDA clearance 6/15/01 Aspect Medical Systems A-2000 EEG Monitor with BIS This 510(k), #K031694, received FDA clearance Qctober 10, 2003 Device Description The Aspect Medical Systems, Inc. EEG BIS Monitor, mode! A-2000 is a… | 2003 |
What descends from it? (303)
See all 3034 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K040183 (Aspect Medical Systems, Inc., 2004) has gone furthest, with 274 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/K030267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030267: 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/K030267
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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