# K021845: Stardust II, Model 1011176

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: May 20, 2004 after 715 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953930 (1996). 9 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973920: Stardust, Respironics, Inc. (1998) Summary page 1.
- K012554: Remstar Auto Cpap System, Respironics, Inc. (2002)
- K031460: Modification to Remstar Auto Cpap System, Respironics, Inc. (2003). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K083575: Apnealink Plus, Model: 22328 (2009), 27 descendants of its own
- K140124: S9 Elouera (2014), 8 descendants of its own
- K132371: Easycare Online (2013), 8 descendants of its own
- K131932: Apnealink Pro (2013), 8 descendants of its own
- K143272: ApneaLink Air (2015), 7 descendants of its own

## Indications for use
The Stardust II is indicated for use by Health Care Professionals to aid in the diagnosis of sleep-related breathing disorders in adult patients weighing more than 30kg in the home, hospital or other clinical setting. The Stardust II is intended for use during sleep disorder studies to detect up to 5 physiological signals: percent SpO2 (functional), pulse rate, oral/nasal airflow, respiratory effort and body position (i.e., supine or non-supine).

Source page: https://510kreport.com/device/K021845
Methodology: https://510kreport.com/methodology