# K974587: H2O

- Pathway: 510(k) (Traditional)
- Applicant: Grass-Telefactor Product Group
- Decided: Mar 9, 1998 after 90 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: 2 generations back to K884937 (1989). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972202: Deeg-Lite, Grass-Telefactor Product Group (1997) Summary page 1.

## Most influential descendants
- K992291: H20- Tethered Option (1999), 8 descendants of its own
- K033978: ADAM (2004), 6 descendants of its own
- K994142: Grass TS3201/6401 Eeg Amplifier System (2000), 6 descendants of its own
- K050425: Aura-PSG (2005), 5 descendants of its own
- K071782: Micromed Brain Spy Plus, Embia Titanium Devices (2008), 4 descendants of its own

## Indications for use
This device is intended for use in long-term recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device. An integrated pulse oximeter provides supplemental diagnostic data in the form of blood oxygen saturation (SpO₂ percent).

Source page: https://510kreport.com/device/K974587
Methodology: https://510kreport.com/methodology