# K250058: NEAT 001

- Pathway: 510(k) (Traditional)
- Applicant: Brain Electrophysiology Laboratory Company, LLC
- Decided: Apr 10, 2025 after 90 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: 9 generations back to K962603 (1997). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162627: EnsoSleep, Ensodata, Inc. (2017) Summary page 5.

## Indications for use
Automatic scoring of sleep EEG data to identify stages of sleep according the American Academy of Sleep Medicine definitions, rules and guidelines. It is to be used with adult populations.

Source page: https://510kreport.com/device/K250058
Methodology: https://510kreport.com/methodology