# K142988: Sleepware G3

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Mar 16, 2015 after 151 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: 5 generations back to K873535 (1987). 16 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040595: ALICE 5, Respironics, Inc. (2004) Summary page 4.
- K131994: Somnolyzer 24X7, Respironics, Inc. (2013) Summary page 4.

## Most influential descendants
- K202142: Sleepware G3 (2020), 2 descendants of its own
- K241960: DeepRESP (2025), 1 descendant of its own
- K250851: Hypnos (369054-200) (2025), 0 descendants 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 infant or adult patients in a clinical environment by or on the order of a physician. The optional Somnolyzer Inside scoring package has the same intended use as Sleepware G3, but is indicated for use with adult patients only.

Source page: https://510kreport.com/device/K142988
Methodology: https://510kreport.com/methodology