# K973920: Stardust

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: May 14, 1998 after 211 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: 1 generation back to K914085 (1991). 2 ancestors in all.
100 later devices descend from it; 3 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914620: HMS-4000 Physiological Monitor, Modification, Vitalog Monitoring,Inc. (1992) Summary page 1.
- K914085: HMS-5000, Vitalog Monitoring,Inc. (1991) Summary page 1.

## Most influential descendants
- K000253: Silent Night V (2000), 69 descendants of its own
- K042745: Lifescreen Apnea (2005), 63 descendants of its own
- K083325: N-600X with SPD, Oximax N-600X (2009), 53 descendants of its own
- K111933: Covidien Nellcor Respiration Rate Software Application, Version 1.0 (2012), 49 descendants of its own
- K121806: Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software (2012), 45 descendants of its own

## Indications for use
The Stardust is indicated for use in the diagnosis of respiratory disorders, such as sleep apnea.

Source page: https://510kreport.com/device/K973920
Methodology: https://510kreport.com/methodology