# K142825: Zmachine

- Pathway: 510(k) (Traditional)
- Applicant: Consolidated Research of Richmond, Inc.
- Decided: Jan 20, 2015 after 112 days
- Product code: OLZ (Automatic Event Detection Software For 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: 6 generations back to K962603 (1997). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101830: Zmachine, Model DT-100, Consolidated Research of Richmond, Inc. (2011) Summary page 5.
- K120450: Sleep Profiler, Advanced Brain Monitoring, Inc. (2012) Summary page 5.

## Indications for use
The CRI 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/K142825
Methodology: https://510kreport.com/methodology