510(k) · Cleared
ClearedBis/Eeg Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · OLW Index-Generating Electroencephalograph Software
Cleared on Oct 1, 2001 as substantially equivalent to K974496 (Aspect Medical Systems, Inc., 1998) and 2 other predicates after a 61-day review. Its family tree reaches back 2 generations to 1996. 305 later devices descend from it.
- Decided
- Oct 1, 2001
- Review
- 61 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K963644 (1996). 5 ancestors in all, the oldest K923043 (1992). 305 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 1 generation backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
- This deviceK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
- Descendant · cites it directly · 304 of its ownK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 303 of its ownK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
- Descendant · 3 generations on · 274 of its ownK040183 BISXAspect Medical Systems, Inc. · 2004
- Descendant · 4 generations on · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- Descendant · 5 generations on · 251 of its ownK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
Showing 5 of 305 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 305 · See all- K031694Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003 · cites it directly304descendants
- K030267Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004 · 2 generations on303descendants
- K040183BISXAspect Medical Systems, Inc. · 2004 · 3 generations on274descendants
- K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · 4 generations on252descendants
- K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2004 · 5 generations on251descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −1 | K974496 | A-2000 Eeg Monitor with Bis | Aspect Medical Systems, Inc. | 1998 | — |
| 0 (this device) | 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 | — |
| +2 | K030267 | Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2004 | — |
| +3 | K040183 | BISX | Aspect Medical Systems, Inc. | 2004 | — |
| +4 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| +5 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 17.0 · 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? (3)
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 |
|---|---|---|---|
| * | K974496 | A-2000 Eeg Monitor with BisSummary page 1…t GE Medical Systems Information Technologies Phone: (414) 382-3328 Fax: (414) 918-8114 Common/Usyal Name: 21 CFR 882.1400 Electroencephalograph Predicate Devices: ) K974496, K923043 & K011843 Aspect Medical Systems, Inc. EEG Monitor with BIS Engine Device Descripfion: 1.0 pis/EEG Module is part of a… | 1998 |
| * | K923043 | Spectral Eeg Monitor Model A1000Summary page 1…cal Systems Information Technologies Phone: (414) 382-3328 Fax: (414) 918-8114 Common/Usyal Name: 21 CFR 882.1400 Electroencephalograph Predicate Devices: ) K974496, K923043 & K011843 Aspect Medical Systems, Inc. EEG Monitor with BIS Engine Device Descripfion: 1.0 pis/EEG Module is part of a modular s… | 1992 |
| * | K011834 | Bis Engine Our OCR of the scanned summary read K011843, FDA’s number for Genzyme Direct-Amylase Test Reagent (Genzyme Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Aspect Medical Systems, Inc. EEG Monitor with BIS Engine”. | 2001 |
What descends from it? (305)
See all 3051 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031694 | Modification to Eeg Monitor with Bis, Model a-2000 | 2003 | 304 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K031694 (Aspect Medical Systems, Inc., 2003) has gone furthest, with 304 descendants of its own.
- 5 other devices also cite its predicate K974496.
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 BIS/EEG Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS/EEG Module 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/EEG Module is intended to monitor the Bispectral index (BIS), a processed EEG variable which 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/K012466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012466: Bis/Eeg Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012466
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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