510(k) · Cleared
Recalled · 2007Stardust II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · MNR Ventilatory Effort Recorder
Cleared on Dec 13, 2005 as substantially equivalent to K021845 (Respironics, Inc., 2004) and 2 other predicates after an 85-day review. Its family tree reaches back 5 generations to 1996. It has been recalled 2 times.
- Decided
- Dec 13, 2005
- Review
- 85 days
- Class
- Class II
- Product code
- MNR
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 5 generations to K953930 (1996). 13 ancestors in all, the oldest K914085 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 4 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 3 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 2 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 1 generation backK021845 Stardust II, Model 1011176Respironics, Inc. · 2004
- This deviceK052573 Stardust IIRespironics, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −4 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −3 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −2 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −1 | K021845 | Stardust II, Model 1011176 | Respironics, Inc. | 2004 | — |
| 0 (this device) | K052573 | Stardust II | Respironics, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021845 | Stardust II, Model 1011176Summary page 1…Class 11 Appropriate Classification Panel Anesthesiology Product Code MNR Predicate Devices Respironics Stardust (K021 845/1K973920) Compumnedics Somte System (K021176) Reason for submission Modifie… | 2004 |
| * | K973920 | StardustSummary page 1…ass 11 Appropriate Classification Panel Anesthesiology Product Code MNR Predicate Devices Respironics Stardust (K021 845/1K973920) Compumnedics Somte System (K021176) Reason for submission Modified design… | 1998 |
| * | K021176 | Compumedics Somte SystemSummary page 1…MNR Predicate Devices Respironics Stardust (K021 845/1K973920) Compumnedics Somte System (K021176) Reason for submission Modified design 09/16/05… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2007 | Not classified | Z-1089-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1087-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- 2 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K021845.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052573: Stardust II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052573
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026