# K021807: Grass-Telefactor AS40 Amplifier System

- Pathway: 510(k) (Traditional)
- Applicant: Grass Instrument Co.
- Decided: Aug 29, 2002 after 87 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: 1 generation back to K000068 (2000). 2 ancestors in all.
471 later devices descend from it; 4 cite it directly.
1 of 474 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003681: Bio-Logic Sleepscan Netlink, Bio-Logic Systems Corp. (2000) Summary page 1.
- K000068: Compumedics E-Series Eeg System, Compumedics Neuro Science Pty, Ltd. (2000) Summary page 1.

## Most influential descendants
- K050798: Eclipse Neurological Workstation (2005), 460 descendants of its own
- K061113: Orthomon (2006), 450 descendants of its own
- K061639: Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and Vascular Doppler; Cardiomon (2006), 426 descendants of its own
- K111520: Ipc Powerease System (2011), 418 descendants of its own
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps (2013), 404 descendants of its own

## Indications for use
The AS40 amplifier system is designed for use in the recording of routine EEG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications (EMG and Evoked Potentials). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.

Source page: https://510kreport.com/device/K021807
Methodology: https://510kreport.com/methodology