# K241960: DeepRESP

- Pathway: 510(k) (Traditional)
- Applicant: Nox Medical Ehf
- Decided: Mar 14, 2025 after 254 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: 7 generations back to K873535 (1987). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192469: Nox Sleep System, Nox Medical (2019) Summary page 5.
- K202142: Sleepware G3, Respironics, Inc. (2020) Summary page 5.

## Most influential descendants
- K252330: DeepRESP (2025), 0 descendants of its own

## Indications for use
DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, patient home, or an ambulatory setting. It is indicated for use with adults (22 years and above) in a clinical environment by or on the order of a medical professional. DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotation of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional.

Source page: https://510kreport.com/device/K241960
Methodology: https://510kreport.com/methodology