# K093728: BE Micro, Trea

- Pathway: 510(k) (Traditional)
- Applicant: Eb Neuro S.P.A.
- Decided: Apr 29, 2010 after 147 days
- Product code: OLV (Standard Polysomnograph With 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: 5 generations back to K962603 (1997). 16 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010460: Lifelines Trackit, Lifelines, Ltd. (2001) Summary page 1.
- K052066: Ceegraph/Sleepscan Netlink Traveler, Bio-Logic Systems Corp. (2005) Summary page 1.
- K061996: Sandman Pocket, Eb Neuro S.P.A. (2006) Summary page 1.

## Most influential descendants
- K133355: Cadwell Flex Eeg/PSG (2014), 3 descendants of its own
- K180269: Cadwell Apollo System (2018), 2 descendants of its own
- K201819: Cadwell Apollo System (2020), 1 descendant of its own
- K221959: Q21 (2023), 0 descendants of its own

## Indications for use
BE micro/Trea intended use is collecting and recording physiological data to be used in neurology (EEG), polysomnography (PSG) and sleep disorder studies. The BE micro is intended for pediatric to adult population, and can be used either home or hospital environments The BE micro/Trea is only to be used under the direction or supervision of a physician, or other trained health care professional.

Source page: https://510kreport.com/device/K093728
Methodology: https://510kreport.com/methodology