# K071782: Micromed Brain Spy Plus, Embia Titanium Devices

- Pathway: 510(k) (Abbreviated)
- Applicant: Micromed S.P.A.
- Decided: Jan 10, 2008 after 192 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: 6 generations back to K884937 (1989). 20 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042150: Xltek Trex Model#10309, Excel Tech., Ltd. (2004) Summary page 1.
- K050425: Aura-PSG, Astro-Med, Inc. (2005) Summary page 1.
- K031202: Medipalm-20, Braebon Medical Corp. (2003) Summary page 1.

## Most influential descendants
- K122196: Cervello Bio-Potential Signal Acquistion System Product Family (2013), 3 descendants of its own
- K133995: Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software (2015), 1 descendant of its own
- K220254: Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (2022), 0 descendants of its own
- K171384: Micromed BRAIN QUICK system (2018), 0 descendants of its own

## Indications for use
The devices are intended to acquire and store physiological signals for EEG and Sleep Studies, and to transfer the data to separate polysomnographic analysis software. The devices are intended for use by physicians, technicians, or other medical professionals that are trained in EEG and/or PSG.

Source page: https://510kreport.com/device/K071782
Methodology: https://510kreport.com/methodology