510(k) · Cleared
ClearedSpacelabs Medical 90482 Bispectral Index Analysis (Bis) Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · OLW Index-Generating Electroencephalograph Software
Cleared on Feb 3, 1998 as substantially equivalent to K963644 (Aspect Medical Systems, Inc., 1996) after a 134-day review. Its family tree reaches back 1 generation to 1996. 30 later devices descend from it.
- Decided
- Feb 3, 1998
- Review
- 134 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963644 (1996). 30 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- This deviceK973596 Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc. · 1998
- Descendant · cites it directly · 29 of its ownK983229 Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
- Descendant · 2 generations on · 25 of its ownK030489 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- Descendant · 3 generations on · 23 of its ownK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- Descendant · 2 generations on · 18 of its ownK020335 Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330Olympic Medical Corp. · 2002
- Descendant · 3 generations on · 17 of its ownK031149 Olympic CFM 6000Olympic Medical Corp. · 2003
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K983229Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999 · cites it directly29descendants
- K030489BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003 · 2 generations on25descendants
- K033010BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003 · 3 generations on23descendants
- K020335Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330Olympic Medical Corp. · 2002 · 2 generations on18descendants
- K031149Olympic CFM 6000Olympic Medical Corp. · 2003 · 3 generations on17descendants
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) | K973596 | Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module | Spacelabs Medical, Inc. | 1998 | — |
| +1 | K983229 | Olympic Medical Lectromed Cerebral Function Monitor System | Olympic Medical Corp. | 1999 | — |
| +2 | K030489 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| +3 | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| +2 | K020335 | Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330 | Olympic Medical Corp. | 2002 | — |
| +3 | K031149 | Olympic CFM 6000 | Olympic Medical Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 17.1 · 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…substantially equivalent to the EEG Monitor, Models A-1000/A-1050 with the Processed Parameter BIS, currently marketed by Aspect Medical Systems, Inc. (510[k] reference K963644). Both monitoring systems provide the means to monitor the state of the brain by data acquisition and processing of EEG signals i… | 1996 |
What descends from it? (30)
See all 301 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983229 | Olympic Medical Lectromed Cerebral Function Monitor System | 1999 | 29 |
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?
Patient conditions indicated by abnormalities in electroencephalograph
(EEG) signals in the brain.
Caution statement is provided in the introductory page of the Patient
Care Information System which includes the operating instructions for this
Module.
Electrodes connected to the Module are applied externally to the scalp.
Frequency as directed by physician.
To monitor the state of the brain by data acquisition of EEG signals
in the intensive care unit, operating room anc for clinical resaarch,
and
To display a 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/K973596 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973596: Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973596
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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