510(k) · Cleared
ClearedBRM2 Brain Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainz Instruments, Ltd. · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Oct 10, 2003 as substantially equivalent to K030489 (Brainz Instruments, Ltd., 2003) and 3 other predicates after a 14-day review. Its family tree reaches back 4 generations to 1996. 23 later devices descend from it.
- Decided
- Oct 10, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K963644 (1996). 13 ancestors in all, the oldest K871179 (1987). 23 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 3 generations backK973596 Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc. · 1998
- 2 generations backK983229 Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
- 1 generation backK030489 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- This deviceK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- Descendant · cites it directly · 15 of its ownK071449 BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007
- Descendant · cites it directly · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 11 of its ownK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- Descendant · 2 generations on · 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
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K071449BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007 · cites it directly15descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · cites it directly14descendants
- K082886Zoom-100DCBrainscope Company, Inc. · 2009 · 2 generations on11descendants
- K081551Twin Neurotrac-IiiAstro-Med, Inc. · 2008 · 2 generations on8descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −3 | K973596 | Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module | Spacelabs Medical, Inc. | 1998 | — |
| −2 | K983229 | Olympic Medical Lectromed Cerebral Function Monitor System | Olympic Medical Corp. | 1999 | — |
| −1 | K030489 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| 0 (this device) | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| +1 | K071449 | BRM3 Brain Monitor | Brainz Instruments, Ltd. | 2007 | — |
| +1 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +2 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
| +2 | K081551 | Twin Neurotrac-Iii | Astro-Med, Inc. | 2008 | — |
| +2 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 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 OLT? 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 OLT device
- #1 K253767 UB ERP Systemscore 14.9 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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…n Monitor Classification Name: Electroencephalograph Neurology Devices, 21 CFR §882.1400, Class I, OI-—'[,O"M/;&V’\{ (a)(3) Identification of Legally Marketed Devices K030489 BRM?2 Brain Monitor Brainz Instruments Ltd K960732 HydroSpot EEG Electrode Model 1501 Physiometrix Inc K911529 Bunny Electrode… | 2003 |
| * | K960732 | Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500Summary page 1…ph Neurology Devices, 21 CFR §882.1400, Class I, OI-—'[,O"M/;&V’\{ (a)(3) Identification of Legally Marketed Devices K030489 BRM?2 Brain Monitor Brainz Instruments Ltd K960732 HydroSpot EEG Electrode Model 1501 Physiometrix Inc K911529 Bunny Electrode / Stealth Electrode Lead-Lok Inc K000206 PALS Neo… | 1996 |
| * | K911529 | Bunny Electrode/Stealth Electrode Pre Wired EegSummary page 1…&V’\{ (a)(3) Identification of Legally Marketed Devices K030489 BRM?2 Brain Monitor Brainz Instruments Ltd K960732 HydroSpot EEG Electrode Model 1501 Physiometrix Inc K911529 Bunny Electrode / Stealth Electrode Lead-Lok Inc K000206 PALS Neonatal Pediatric ECG Electrode ~ Axelgaard Manufacturing Co Lt… | 1992 |
| * | K000206 | Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200Summary page 1…030489 BRM?2 Brain Monitor Brainz Instruments Ltd K960732 HydroSpot EEG Electrode Model 1501 Physiometrix Inc K911529 Bunny Electrode / Stealth Electrode Lead-Lok Inc K000206 PALS Neonatal Pediatric ECG Electrode ~ Axelgaard Manufacturing Co Ltd (a)(4) Description of the Device The BRM2 Brain Monitor… | 2000 |
What descends from it? (23)
See all 232 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 7 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K071449 (Brainz Instruments, Ltd., 2007) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K030489.
How does its category compare?
All OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, 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 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
What is it indicated for?
The Brainz Instruments Ltd BRM2 Brain Monitor is an Electroencephalograph 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 electrodes on the head).
The BRM2 Brain Monitor is intended to monitor the state of the brain by acquisition of electroencephalogram (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/K033010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033010: BRM2 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/K033010
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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