510(k) · Cleared
ClearedStardust II, Model 1011176
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 May 20, 2004 as substantially equivalent to K973920 (Respironics, Inc., 1998) and 2 other predicates after a 715-day review. Its family tree reaches back 4 generations to 1996. 29 later devices descend from it.
- Decided
- May 20, 2004
- Review
- 715 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K953930 (1996). 9 ancestors in all, the oldest K914085 (1991). 29 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 3 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 2 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 1 generation backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- This deviceK021845 Stardust II, Model 1011176Respironics, Inc. · 2004
- Descendant · cites it directly · 27 of its ownK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK140124 S9 EloueraResmed Corp · 2014
- Descendant · 2 generations on · 8 of its ownK132371 Easycare OnlineResmed, Ltd. · 2013
- Descendant · 2 generations on · 8 of its ownK131932 Apnealink ProResmed Germany, Inc. · 2013
- Descendant · 3 generations on · 7 of its ownK143272 ApneaLink AirResmed Germany, Inc. · 2015
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K083575Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009 · cites it directly27descendants
- K140124S9 EloueraResmed Corp · 2014 · 2 generations on8descendants
- K132371Easycare OnlineResmed, Ltd. · 2013 · 2 generations on8descendants
- K131932Apnealink ProResmed Germany, Inc. · 2013 · 2 generations on8descendants
- K143272ApneaLink AirResmed Germany, Inc. · 2015 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −3 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −2 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −1 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| 0 (this device) | K021845 | Stardust II, Model 1011176 | Respironics, Inc. | 2004 | — |
| +1 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| +2 | K140124 | S9 Elouera | Resmed Corp | 2014 | — |
| +2 | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
| +2 | K131932 | Apnealink Pro | Resmed Germany, Inc. | 2013 | — |
| +3 | K143272 | ApneaLink Air | Resmed Germany, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K973920 | StardustSummary page 1…MN R -Ventilatory Effort Recorder Proprietary Name Respironics Stardust 11 Predicate Device(s) Respironics Stardust (K973920) Respironics REMstar Auto (K0l 2554/K03 1460) Reason for submission Modified de… | 1998 |
| * | K012554 | Remstar Auto Cpap System | 2002 |
| * | K031460 | Modification to Remstar Auto Cpap System Cleared while this submission was under review Summary page 1…Respironics Stardust 11 Predicate Device(s) Respironics Stardust (K973920) Respironics REMstar Auto (K0l 2554/K03 1460) Reason for submission Modified design/intended use. Substantial Equivalence The modified device has the fo… | 2003 |
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K083575 (Resmed Germany, Inc., 2009) has gone furthest, with 27 descendants of its own.
- 2 other devices also cite its predicate K973920.
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 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021845: Stardust II, Model 1011176.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021845
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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