# K012976: Twin Plus

- Pathway: 510(k) (Traditional)
- Applicant: Grass-Telefactor Divison
- Decided: Feb 12, 2002 after 160 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 K870450 (1987). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870450: Szac-16 Seizure Analysis Computer, Grass-Telefactor Product Group (1987) Summary page 2.
- (no number) GRASS GAMMA software: named in the summary without a submission number
- (no number) Telefactor BEEHIVE: named in the summary without a submission number

## Most influential descendants
- K173366: NicoletOne (2018), 3 descendants of its own
- K142064: Galileo NT (2015), 2 descendants of its own
- K200878: Natus NeuroWorks (2020), 1 descendant of its own
- K251881: HippoMind (v1.0) (2025), 0 descendants of its own
- K242832: NExT Station; NExT Station Advanced (2024), 0 descendants of its own

## Indications for use
This software is intended for use by qualified research and clinical professionals with specialized training in the use of EEG and PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. It is suitable for digital acquisition, display, comparison, analysis, and archiving of EEG potentials and other rapidly changing physiological parameters.

Source page: https://510kreport.com/device/K012976
Methodology: https://510kreport.com/methodology