510(k) · Cleared
ClearedOlympic Medical Lectromed Cerebral Function Monitor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympic Medical Corp. · OMA Amplitude-Integrated Electroencephalograph
Cleared on Mar 23, 1999 as substantially equivalent to K974496 (Aspect Medical Systems, Inc., 1998) and 1 other predicate after a 189-day review. Its family tree reaches back 2 generations to 1996. 29 later devices descend from it.
- Decided
- Mar 23, 1999
- Review
- 189 days
- Class
- Class II
- Product code
- OMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963644 (1996). 3 ancestors in all. 29 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 1 generation backK973596 Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc. · 1998
- This deviceK983229 Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
- Descendant · cites it directly · 25 of its ownK030489 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- Descendant · 2 generations on · 23 of its ownK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- Descendant · cites it directly · 18 of its ownK020335 Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330Olympic Medical Corp. · 2002
- Descendant · 2 generations on · 17 of its ownK031149 Olympic CFM 6000Olympic Medical Corp. · 2003
- Descendant · cites it directly · 15 of its ownK071449 BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K030489BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003 · cites it directly25descendants
- K033010BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003 · 2 generations on23descendants
- K020335Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330Olympic Medical Corp. · 2002 · cites it directly18descendants
- K031149Olympic CFM 6000Olympic Medical Corp. · 2003 · 2 generations on17descendants
- K071449BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007 · cites it directly15descendants
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 | K973596 | Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module | Spacelabs Medical, Inc. | 1998 | — |
| 0 (this device) | K983229 | Olympic Medical Lectromed Cerebral Function Monitor System | Olympic Medical Corp. | 1999 | — |
| +1 | K030489 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| +2 | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| +1 | K020335 | Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330 | Olympic Medical Corp. | 2002 | — |
| +2 | K031149 | Olympic CFM 6000 | Olympic Medical Corp. | 2003 | — |
| +1 | K071449 | BRM3 Brain Monitor | Brainz Instruments, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OMA? 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 OMA device
- #1 K192889 Neoscore -1.2 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K974496 | A-2000 Eeg Monitor with BisSummary page 1…acquisition of EEG signals in the intensive care unit, operating room, and for clinical research. Predicate Device Aspect Medical Systems A-2000 EEG Monitor with BIS. (K974496) Spacelabs 90482 EEG BIS Module (K973596) Device Description The Olympic Medical Lectromed Cerebral Function Monitor System cons… | 1998 |
| * | K973596 | Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSummary page 1…ive care unit, operating room, and for clinical research. Predicate Device Aspect Medical Systems A-2000 EEG Monitor with BIS. (K974496) Spacelabs 90482 EEG BIS Module (K973596) Device Description The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifie… | 1998 |
What descends from it? (29)
See all 294 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 3 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K030489 (Brainz Instruments, Ltd., 2003) has gone furthest, with 25 descendants of its own.
- 5 other devices also cite its predicate K974496.
How does its category compare?
All OMA devicesOMA Amplitude-Integrated Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OMA
Too few OMA 510(k)s in any year since 2007 to give a median.
Recalls per year · OMA
No recall names OMA since 2007.
Adverse event reports per year · OMA
2in 2024
MAUDE reports naming product code OMA, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to monitor the state of the brain by acquisition of EEG signals in the intensive care unit, operating room, and for clinical research.
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/K983229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983229: Olympic Medical Lectromed Cerebral Function Monitor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983229
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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