510(k) · Cleared
ClearedOlympic Medical Lectromed Cerebral Function Monitor System, Model 5330
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympic Medical Corp. · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Jun 18, 2002 as substantially equivalent to K983229 (Olympic Medical Corp., 1999) and 1 other predicate after a 137-day review. Its family tree reaches back 3 generations to 1996. 18 later devices descend from it.
- Decided
- Jun 18, 2002
- Review
- 137 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K963644 (1996). 5 ancestors in all, the oldest K791580 (1979). 18 later devices descend from it, 1 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 deviceK020335 Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330Olympic Medical Corp. · 2002
- Descendant · cites it directly · 17 of its ownK031149 Olympic CFM 6000Olympic Medical Corp. · 2003
- Descendant · 2 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 8 of its ownK081551 Twin Neurotrac-IiiAstro-Med, Inc. · 2008
- Descendant · 3 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- Descendant · 4 generations on · 5 of its ownK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K031149Olympic CFM 6000Olympic Medical Corp. · 2003 · cites it directly17descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 2 generations on14descendants
- K081551Twin Neurotrac-IiiAstro-Med, Inc. · 2008 · 2 generations on8descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 3 generations on7descendants
- K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012 · 4 generations on5descendants
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) | K020335 | Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330 | Olympic Medical Corp. | 2002 | — |
| +1 | K031149 | Olympic CFM 6000 | Olympic Medical Corp. | 2003 | — |
| +2 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +2 | K081551 | Twin Neurotrac-Iii | Astro-Med, Inc. | 2008 | — |
| +3 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| +4 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 OMC? 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 OMC device
- #1 K251550 NX01 (NX01)score 13.1 · 10 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 |
|---|---|---|---|
| * | K983229 | Olympic Medical Lectromed Cerebral Function Monitor SystemSummary page 1…quisition of EEG signals in the intensive care unit, operating room, and for clinical research. Predicate Device - Olympic Medical Lectromed Cerebral Function Monitor (K983229). - Devices Limited Cerebral Function Monitor 4640 in commercial distribution in the U. S. prior to May 28, 1976. - Applied Med… | 1999 |
| * | K791580 | Cerebral Function Monitor 870Summary page 1…erebral Function Monitor 4640 in commercial distribution in the U. S. prior to May 28, 1976. - Applied Medical Research Corporation Cerebral Function Monitor Model 870 (K791580) Device Description The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifie… | 1979 |
| * | — | Devices Limited Cerebral Function Monitor 4640 Named without a submission number |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031149 | Olympic CFM 6000 | 2003 | 17 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K031149 (Olympic Medical Corp., 2003) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K983229.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMC
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMC
No recall names OMC since 2007.
Adverse event reports per year · OMC
2in 2025
MAUDE reports naming product code OMC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 3 | 56 | 0 | 2 |
| 2025 | 3 | 172 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to be used by a variety of clinicians to acquire and utilize EEG signals, when used in conjunction with other clinical data, in intensive care areas, Operating Room, Emergency Room, and clinical research lab: - to monitor the state of the brain - for determination of, and long-term monitoring of, the neurological status of patients that may have suffered an hypoxic-ischemic event.…
Read the full statement (151 words)
The Olympic Medical Lectromed Cerebral Function Monitor System is intended
to be used by a variety of clinicians to acquire and utilize EEG signals, when
used in conjunction with other clinical data, in intensive care areas, Operating
Room, Emergency Room, and clinical research lab:
- to monitor the state of the brain
- for determination of, and long-term monitoring of, the neurological status of
patients that may have suffered an hypoxic-ischemic event.
- for monitoring of neurological status to assist in the clinical management
and treatment of the patient by observing how the treatment affects the
neurological status as shown by the CFM.
- to assist in the prediction of neurological outcome
- to monitor and record frequency and intensity of seizures to assist in
management of anti-convulsive therapy.
- to assist in the prediction of severity of Hypoxic-Ischemic Encephalopathy
and long-term outcome in infants who have suffered an hypoxic-ischemic
event.
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/K020335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020335: Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020335
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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