# K061764: Medibyte, Model MP8

- Pathway: 510(k) (Traditional)
- Applicant: Braebon Medical Corp.
- Decided: Sep 6, 2006 after 76 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981445 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031202: Medipalm-20, Braebon Medical Corp. (2003) Summary page 2.
- K984431: Ultima Airflow Pressure Sensor, Braebon Medical Corp. (1998) Summary page 2.
- K982216: Ultima Respiratory Effort Sensor Models 0520 and 0522, Braebon Medical Corp. (1998) Summary page 2.
- K020312: Ultima Snoring Mike, Model 0540, Braebon Medical Corp. (2002) Summary page 2.

## Indications for use
The MediByte TM is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. The data is downloaded after the recording is completed and the auto assist software enables the trained human professional - typically a Registered Sleep Technologist or Medical Doctor - to verify the results of the study and generate a report. Target Population: Children and adult patients who are screened during sleep disorder studies. Environment of Use The majority of the screenings occur either in the home at in a clinical setting.

Source page: https://510kreport.com/device/K061764
Methodology: https://510kreport.com/methodology