510(k) · Cleared
ClearedCerebral Function Monitor 870
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Research · OMA Amplitude-Integrated Electroencephalograph
Cleared on Sep 4, 1979 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Sep 4, 1979
- Review
- 18 days
- Class
- Class II
- Product code
- OMA
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 1 citing it directly.
- This deviceK791580 Cerebral Function Monitor 870Applied Medical Research · 1979
- 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 · 3 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 8 of its ownK081551 Twin Neurotrac-IiiAstro-Med, Inc. · 2008
- Descendant · 4 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K020335Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330Olympic Medical Corp. · 2002 · cites it directly18descendants
- K031149Olympic CFM 6000Olympic Medical Corp. · 2003 · 2 generations on17descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 3 generations on14descendants
- K081551Twin Neurotrac-IiiAstro-Med, Inc. · 2008 · 3 generations on8descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K791580 | Cerebral Function Monitor 870 | Applied Medical Research | 1979 | — |
| +1 | K020335 | Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330 | Olympic Medical Corp. | 2002 | — |
| +2 | K031149 | Olympic CFM 6000 | Olympic Medical Corp. | 2003 | — |
| +3 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +3 | K081551 | Twin Neurotrac-Iii | Astro-Med, Inc. | 2008 | — |
| +4 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020335 | Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330 | 2002 | 18 |
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?
- Of its descendants, K020335 (Olympic Medical Corp., 2002) has gone furthest, with 18 descendants of its own.
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 | — |
https://510kreport.com/device/K791580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K791580: Cerebral Function Monitor 870.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K791580
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026