510(k) · Cleared
ClearedBRM3 Brain Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainz Instruments, Ltd. · OMA Amplitude-Integrated Electroencephalograph
Cleared on Sep 14, 2007 as substantially equivalent to K030489 (Brainz Instruments, Ltd., 2003) and 2 other predicates after a 113-day review. Its family tree reaches back 5 generations to 1996. 15 later devices descend from it.
- Decided
- Sep 14, 2007
- Review
- 113 days
- Class
- Class II
- Product code
- OMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K963644 (1996). 14 ancestors in all, the oldest K871179 (1987). 15 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 4 generations backK973596 Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc. · 1998
- 3 generations backK983229 Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
- 2 generations backK030489 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- 1 generation backK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- This deviceK071449 BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007
- Descendant · cites it directly · 11 of its ownK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK081551 Twin Neurotrac-IiiAstro-Med, Inc. · 2008
- Descendant · 2 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- Descendant · 2 generations on · 6 of its ownK092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010
- Descendant · 3 generations on · 5 of its ownK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K082886Zoom-100DCBrainscope Company, Inc. · 2009 · cites it directly11descendants
- K081551Twin Neurotrac-IiiAstro-Med, Inc. · 2008 · cites it directly8descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 2 generations on7descendants
- K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010 · 2 generations on6descendants
- K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −4 | K973596 | Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module | Spacelabs Medical, Inc. | 1998 | — |
| −3 | K983229 | Olympic Medical Lectromed Cerebral Function Monitor System | Olympic Medical Corp. | 1999 | — |
| −2 | K030489 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| −1 | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| 0 (this device) | K071449 | BRM3 Brain Monitor | Brainz Instruments, Ltd. | 2007 | — |
| +1 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
| +1 | K081551 | Twin Neurotrac-Iii | Astro-Med, Inc. | 2008 | — |
| +2 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| +2 | K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | 2010 | — |
| +3 | K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K030489 | BRM2 Brain MonitorSummary page 1…ain Monitor Classification Name: Electroencephalograph Neurology Devices, 21 CFR §882.1400, Class Il, DM -, 0MC, OLT {a)(3) Identification of Legally Marketed Devices K030489 BRM2 Brain Monitor Brainz Instruments Ltd K033010 BRM2 Brain Monitor Brainz Instruments Ltd K983229 Lectromed Cerebral Function M… | 2003 |
| * | K033010 | BRM2 Brain MonitorSummary page 1…graph Neurology Devices, 21 CFR §882.1400, Class Il, DM -, 0MC, OLT {a)(3) Identification of Legally Marketed Devices K030489 BRM2 Brain Monitor Brainz Instruments Ltd K033010 BRM2 Brain Monitor Brainz Instruments Ltd K983229 Lectromed Cerebral Function Monitor Olympic Medical Corp (a){4) Description of… | 2003 |
| * | K983229 | Olympic Medical Lectromed Cerebral Function Monitor SystemSummary page 1…l, DM -, 0MC, OLT {a)(3) Identification of Legally Marketed Devices K030489 BRM2 Brain Monitor Brainz Instruments Ltd K033010 BRM2 Brain Monitor Brainz Instruments Ltd K983229 Lectromed Cerebral Function Monitor Olympic Medical Corp (a){4) Description of the Device The BRM3 Brain Monitor is a three-cha… | 1999 |
What descends from it? (15)
See all 152 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 11 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K082886 (Brainscope Company, Inc., 2009) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K030489.
How does its category compare?
All OMA devicesOMA Amplitude-Integrated Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Brainz Instruments Lid BRM3 Brain Monitor is an electroencephalograph or EEG system, as per 21 CFR §882.1400: a device used to measure and record the electrical activity of the patient’s brain obtained by placing two or more electredes on the head. . The BRM3 Brain Monitor is intended for use lo monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in clinical environments such as the intensive care unit, and for…
Read the full statement (124 words)
The Brainz Instruments Lid BRM3 Brain Monitor is an electroencephalograph or EEG system, as per 21 CFR §882.1400: a device used to measure and record the electrical activity of the patient’s brain obtained by placing two or more electredes on the head.
. The BRM3 Brain Monitor is intended for use lo monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in clinical environments such as the intensive care unit, and for clinical research.
. The BRM3 Brain Monitor is intended for use only with neonalal patients, defined as from birth o 28 days post-delivery, and corresponding to a post-conceptual age of 24 to 46 weeks.
« The BRM3 Brain Monitor does not provide any diagnostic conclusion about the patient’s condition.
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/K071449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071449: BRM3 Brain Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071449
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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