# K101830: Zmachine, Model DT-100

- Pathway: 510(k) (Traditional)
- Applicant: Consolidated Research of Richmond, Inc.
- Decided: Mar 31, 2011 after 273 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 K021485 (2002). 1 ancestor in all.
10 later devices descend from it; 4 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)
- K021485: Biosomnia, Oxford Biosignals Limited (2002) Summary page 2.

## Most influential descendants
- K142834: DiscoverEEG System, Model DE-401 (2015), 5 descendants of its own
- K213299: Wireless EEG System (2022), 2 descendants of its own
- K172986: Zmachine Synergy (2017), 2 descendants of its own
- K192549: Byteflies Kit (2020), 1 descendant of its own
- K254213: Pascall Sensor Unit (PSU1) (2026), 0 descendants of its own

## Indications for use
The CR1 Zmachine is a single-channel, EEG acquisition and analysis system, designed for use in the home or clinical environments. This device is intended to be used by qualified healthcare practitioners to monitor the wake and sleep states of adult patients and as an adjunct to their diagnosis of sleep disorders.

Source page: https://510kreport.com/device/K101830
Methodology: https://510kreport.com/methodology