# K202142: Sleepware G3

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Oct 29, 2020 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: 6 generations back to K873535 (1987). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142988: Sleepware G3, Respironics, Inc. (2015) Summary page 4.

## Most influential descendants
- K241960: DeepRESP (2025), 1 descendant of its own
- K252330: DeepRESP (2025), 0 descendants of its own

## Indications for use
Sleepware G3 is a software application used for analysis (automatic and manual scoring), display, retrieval, summarization, report generation, and networking of data received from monitoring devices used to categorize sleep related events that help aid in the diagnosis of sleep-related disorders. It is indicated for use with adults (18 and older) and infant patients (one year old or less) in a clinical environment by or on the order of a physician. The optional Somnolyzer scoring algorithms are for use with adults (18 and older) to generate an output that is ready for review and interpretation by a physician. Cardio-Respiratory Sleep Staging (CReSS) is an additional functionality of Somnolyzer which uses standard Home Sleep Apnea Test HSAT signals (in the absence of EEG signals) to infer sleep stage.

Source page: https://510kreport.com/device/K202142
Methodology: https://510kreport.com/methodology