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 May 2, 2003 as substantially equivalent to K974496 (Aspect Medical Systems, Inc., 1998) and 2 other predicates after a 77-day review. Its family tree reaches back 3 generations to 1996. 25 later devices descend from it.
- Decided
- May 2, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K963644 (1996). 8 ancestors in all, the oldest K871179 (1987). 25 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 2 generations backK973596 Spacelabs Medical 90482 Bispectral Index Analysis (Bis) ModuleSpacelabs Medical, Inc. · 1998
- 1 generation backK983229 Olympic Medical Lectromed Cerebral Function Monitor SystemOlympic Medical Corp. · 1999
- This deviceK030489 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- Descendant · cites it directly · 23 of its ownK033010 BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003
- Descendant · cites it directly · 15 of its ownK071449 BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007
- Descendant · 2 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · cites it directly · 12 of its ownK072382 Model I-2000 MonitorInfinite Biomedical Technologies · 2008
- Descendant · 2 generations on · 11 of its ownK082886 Zoom-100DCBrainscope Company, Inc. · 2009
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K033010BRM2 Brain MonitorBrainz Instruments, Ltd. · 2003 · cites it directly23descendants
- K071449BRM3 Brain MonitorBrainz Instruments, Ltd. · 2007 · cites it directly15descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 2 generations on14descendants
- K072382Model I-2000 MonitorInfinite Biomedical Technologies · 2008 · cites it directly12descendants
- K082886Zoom-100DCBrainscope Company, Inc. · 2009 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −2 | 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 | — |
| 0 (this device) | K030489 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| +1 | K033010 | BRM2 Brain Monitor | Brainz Instruments, Ltd. | 2003 | — |
| +1 | K071449 | BRM3 Brain Monitor | Brainz Instruments, Ltd. | 2007 | — |
| +2 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +1 | K072382 | Model I-2000 Monitor | Infinite Biomedical Technologies | 2008 | — |
| +2 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 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? (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…sification Name: Electroencephalograph . Neurology Devices, 21 CFR §882.1400, Clasg I1, OLI; oG de ation o all ted Devices Aspect Medical Systems Inc A2000 EEG Monitor K974496 Olympic Medical Corp Lectromed CFM K983229 . Fisher & Paykel Healthcare Ltd PW810 Paticnt Warmer K982636 a D ofthe The BRM2 Brai… | 1998 |
| * | K983229 | Olympic Medical Lectromed Cerebral Function Monitor SystemSummary page 1…eurology Devices, 21 CFR §882.1400, Clasg I1, OLI; oG de ation o all ted Devices Aspect Medical Systems Inc A2000 EEG Monitor K974496 Olympic Medical Corp Lectromed CFM K983229 . Fisher & Paykel Healthcare Ltd PW810 Paticnt Warmer K982636 a D ofthe The BRM2 Brain Monitor is a two-channe] BEG device, cons… | 1999 |
| * | K982636 | Patient Warmer- Model PW810Summary page 1…n o all ted Devices Aspect Medical Systems Inc A2000 EEG Monitor K974496 Olympic Medical Corp Lectromed CFM K983229 . Fisher & Paykel Healthcare Ltd PW810 Paticnt Warmer K982636 a D ofthe The BRM2 Brain Monitor is a two-channe] BEG device, consisting of Skin Electcodes, Sensor Lecad, Acquisition Unit, Iso… | 1998 |
What descends from it? (25)
See all 253 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 8 ancestors has a recall of any class.
- Of its descendants, K033010 (Brainz Instruments, Ltd., 2003) has gone furthest, with 23 descendants of its own.
- 5 other devices also cite its predicate K974496.
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/K030489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030489: 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/K030489
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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