510(k) · Cleared
ClearedModel I-2000 Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinite Biomedical Technologies · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Feb 15, 2008 as substantially equivalent to K030489 (Brainz Instruments, Ltd., 2003) and 1 other predicate after a 175-day review. Its family tree reaches back 4 generations to 1996. 12 later devices descend from it.
- Decided
- Feb 15, 2008
- Review
- 175 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K963644 (1996). 11 ancestors in all, the oldest K871179 (1987). 12 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 deviceK072382 Model I-2000 MonitorInfinite Biomedical Technologies · 2008
- Descendant · cites it directly · 11 of its ownK082886 Zoom-100DCBrainscope Company, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K082886Zoom-100DCBrainscope Company, Inc. · 2009 · cites it directly11descendants
- K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010 · cites it directly6descendants
- K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015 · 2 generations on5descendants
- K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012 · 2 generations on5descendants
- K213299Wireless EEG SystemPascall Systems, Inc. · 2022 · 3 generations on2descendants
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) | K072382 | Model I-2000 Monitor | Infinite Biomedical Technologies | 2008 | — |
| +1 | K082886 | Zoom-100DC | Brainscope Company, Inc. | 2009 | — |
| +1 | K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | 2010 | — |
| +2 | K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015 | — |
| +2 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
| +3 | K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K030489 | BRM2 Brain MonitorSummary page 1…r Usual Name Electroencephalograph Classification Name Electroencephalograph (CFR 882.1400, Class I1) Predicate Devices BrainZ Instruments Ltd. - BRM2 Brain Monitor (K030489) Excel Tech Ltd. — Xltek EMU40 EEG Headbox (K053386) Intended Use / Indications for Use The 1-2000 Monitor is intended to be use… | 2003 |
| * | K053386 | Xltek EMU40 Eeg Headbox, Model PK1072Summary page 1…Name Electroencephalograph (CFR 882.1400, Class I1) Predicate Devices BrainZ Instruments Ltd. - BRM2 Brain Monitor (K030489) Excel Tech Ltd. — Xltek EMU40 EEG Headbox (K053386) Intended Use / Indications for Use The 1-2000 Monitor is intended to be used for measuring and recording the electrical activit… | 2006 |
What descends from it? (12)
See all 122 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 12 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 11 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 OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 I - 2000 Monitor is an electroencephalograph as per CFR §882.1400. It is used to measure
and record the electrical activity of a patient’s brain, obtained by placing electrodes on the head.
The I-2000 Monitor is intended to monitor the state of the brain by acquisition of
electroencephalogram (EEG) signals, in research and clinical environments.
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/K072382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072382: Model I-2000 Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072382
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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