# K031149: Olympic CFM 6000

- Pathway: 510(k) (Special)
- Applicant: Olympic Medical Corp.
- Decided: May 14, 2003 after 34 days
- Product code: OMA (Amplitude-Integrated Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963644 (1996). 6 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020335: Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330, Olympic Medical Corp. (2002) Summary page 1.

## Most influential descendants
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K081551: Twin Neurotrac-Iii (2008), 8 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own
- K173366: NicoletOne (2018), 3 descendants of its own

## Indications for use
The Olympic CFM 6000 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.

Source page: https://510kreport.com/device/K031149
Methodology: https://510kreport.com/methodology