# K052573: Stardust II

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Dec 13, 2005 after 85 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953930 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021845: Stardust II, Model 1011176, Respironics, Inc. (2004) Summary page 1.
- K973920: Stardust, Respironics, Inc. (1998) Summary page 1.
- K021176: Compumedics Somte System, Compumedics Limited (2003) Summary page 1.

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1089-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1087-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

## Indications for use
The Stardust II is a multi-function recording device intended to be used to collect and store physiological signals related to sleep disorders and to aid in the diagnosis of related respiratory sleep disorders. The Stardust II is only to be used under the direction and supervision of a physician, technologist or clinician.

Source page: https://510kreport.com/device/K052573
Methodology: https://510kreport.com/methodology