# K162140: RemLogic

- Pathway: 510(k) (Traditional)
- Applicant: Embla Systems
- Decided: Dec 1, 2016 after 122 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: 2 generations back to K830295 (1983). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971813: EMBLA, Ferguson Medical (1998) Summary page 4.
- K090277: Natus Sleepworks, Model 104017, Excel-Tech Ltd. (Xltek) (2011) Summary page 4.

## Indications for use
The RemLogic software is intended for Polysomnography studies and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The RemLogic software allows: Automated analysis of physiological signals that is intended for use only in adults; An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units. Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values; The RemLogic software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

Source page: https://510kreport.com/device/K162140
Methodology: https://510kreport.com/methodology