# K021485: Biosomnia

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Biosignals Limited
- Decided: Sep 11, 2002 after 126 days
- Product code: OMC (Reduced- Montage Standard 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
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K101830: Zmachine, Model DT-100 (2011), 10 descendants of its own
- K142834: DiscoverEEG System, Model DE-401 (2015), 5 descendants of its own
- K213299: Wireless EEG System (2022), 2 descendants of its own
- K172986: Zmachine Synergy (2017), 2 descendants of its own
- K192549: Byteflies Kit (2020), 1 descendant of its own

## Indications for use
The Oxford BioSignals BioSomnia is a single channel ambulatory EEG with a software package designed for use as an adjunct for the physician in their diagnosis of sleep disorders and to quantify sleep and wakefulness on a second by second basis. The device is designed to be used overnight in the patient’s home environment to assist the physician in diagnosing sleep disorders.

Source page: https://510kreport.com/device/K021485
Methodology: https://510kreport.com/methodology