# K033978: ADAM

- Pathway: 510(k) (Traditional)
- Applicant: Astro-Med, Inc.
- Decided: Feb 18, 2004 after 57 days
- Product code: GWQ (Full-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
Longest line of descent: 4 generations back to K884937 (1989). 7 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992291: H20- Tethered Option, Grass-Telefactor Product Group (1999) Summary page 1.
- K974587: H2O, Grass-Telefactor Product Group (1998) Summary page 1.
- K021807: Grass-Telefactor AS40 Amplifier System, Grass Instrument Co. (2002) Summary page 1.

## Most influential descendants
- K050425: Aura-PSG (2005), 5 descendants of its own
- 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

## Indications for use
The ADAM amplifier system is intended for recording routine EEG and EEG associated with long term monitoring for epilepsy. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.

Source page: https://510kreport.com/device/K033978
Methodology: https://510kreport.com/methodology