# K050425: Aura-PSG

- Pathway: 510(k) (Traditional)
- Applicant: Astro-Med, Inc.
- Decided: Oct 20, 2005 after 244 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 K884937 (1989). 11 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994142: Grass TS3201/6401 Eeg Amplifier System, Grass Instrument Co. (2000) Summary page 1.
- K021807: Grass-Telefactor AS40 Amplifier System, Grass Instrument Co. (2002) Summary page 1.
- K033978: ADAM, Astro-Med, Inc. (2004) Summary page 1.

## Most influential descendants
- K071782: Micromed Brain Spy Plus, Embia Titanium Devices (2008), 4 descendants of its own
- 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 AURA-PSG amplifier system is intended for recording routine Electroencephalography (EEG) and Polysomnography (PSG). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in EEG and/or PSG.

Source page: https://510kreport.com/device/K050425
Methodology: https://510kreport.com/methodology