# K992291: H20- Tethered Option

- Pathway: 510(k) (Special)
- Applicant: Grass-Telefactor Product Group
- Decided: Aug 6, 1999 after 30 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: 3 generations back to K884937 (1989). 3 ancestors in all.
8 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)
- K974587: H2O, Grass-Telefactor Product Group (1998) Summary page 1.

## Most influential descendants
- 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
- K122196: Cervello Bio-Potential Signal Acquistion System Product Family (2013), 3 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/K992291
Methodology: https://510kreport.com/methodology