510(k) · Cleared
ClearedBis Eeg Monitor, Model a-3000
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 Sep 9, 2005 as substantially equivalent to K030267 (Aspect Medical Systems, Inc., 2004) and 1 other predicate after an 11-day review. Its family tree reaches back 6 generations to 1996. 10 later devices descend from it.
- Decided
- Sep 9, 2005
- Review
- 11 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K963644 (1996). 10 ancestors in all, the oldest K923043 (1992). 10 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 5 generations backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
- 4 generations backK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
- 3 generations backK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
- 2 generations backK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
- 1 generation backK040183 BISXAspect Medical Systems, Inc. · 2004
- This deviceK052362 Bis Eeg Monitor, Model a-3000Aspect Medical Systems, Inc. · 2005
- Descendant · cites it directly · 9 of its ownK062613 Bis Eeg Monitor ViewAspect Medical Systems, Inc. · 2007
- Descendant · cites it directly · 8 of its ownK072286 Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 2 of its ownK131898 A Series and Q Series Patient MonitorsGuangdong Biolight Meditech Co., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK230693 BIS™ Advance Monitoring SystemCovidien, LLC · 2024
- Descendant · 3 generations on · 1 of its ownK183687 LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K062613Bis Eeg Monitor ViewAspect Medical Systems, Inc. · 2007 · cites it directly9descendants
- K072286Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 2007 · cites it directly8descendants
- K131898A Series and Q Series Patient MonitorsGuangdong Biolight Meditech Co., Ltd. · 2014 · 2 generations on2descendants
- K230693BIS™ Advance Monitoring SystemCovidien, LLC · 2024 · 2 generations on1descendant
- K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −5 | K974496 | A-2000 Eeg Monitor with Bis | Aspect Medical Systems, Inc. | 1998 | — |
| −4 | K012466 | Bis/Eeg Module | General Electric Medical Systems Information Techn | 2001 | — |
| −3 | K031694 | Modification to Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2003 | — |
| −2 | K030267 | Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2004 | — |
| −1 | K040183 | BISX | Aspect Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K052362 | Bis Eeg Monitor, Model a-3000 | Aspect Medical Systems, Inc. | 2005 | — |
| +1 | K062613 | Bis Eeg Monitor View | Aspect Medical Systems, Inc. | 2007 | — |
| +1 | K072286 | Bis Eeg Vista Monitor System and Bisx | Aspect Medical Systems, Inc. | 2007 | 1 |
| +2 | K131898 | A Series and Q Series Patient Monitors | Guangdong Biolight Meditech Co., Ltd. | 2014 | — |
| +2 | K230693 | BIS™ Advance Monitoring System | Covidien, LLC | 2024 | — |
| +3 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K030267 | Eeg Monitor with Bis, Model a-2000Summary page 1…classified by the Neurological Devices Panel as Class II devices (21 CFR 882.1400) Predicate Devices Aspect Medical Systems A-2000 EEG Monitor with BIS This 5 10(k), #K030267, received FDA clearance 1/15/04 Aspect Medical Systems BISx This 510(k), K040183, received FDA clearance 2/25/04 Device Descrip… | 2004 |
| * | K040183 | BISXSummary page 1…) Predicate Devices Aspect Medical Systems A-2000 EEG Monitor with BIS This 5 10(k), #K030267, received FDA clearance 1/15/04 Aspect Medical Systems BISx This 510(k), K040183, received FDA clearance 2/25/04 Device Description The Aspect Medical Systems, Inc. BIS EEG Monitor, A-3000 is an easy to use, m… | 2004 |
What descends from it? (10)
2 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 9 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K062613 (Aspect Medical Systems, Inc., 2007) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K030267.
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 Medical Systems BIS EEG Monitor, A-3000, 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 as stated in the FDA summary.
https://510kreport.com/device/K052362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052362: Bis Eeg Monitor, Model a-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052362
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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