510(k) · Cleared
ClearedStardust
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 14, 1998 as substantially equivalent to K914620 (Vitalog Monitoring,Inc., 1992) and 1 other predicate after a 211-day review. Its family tree reaches back 1 generation to 1991. 100 later devices descend from it.
- Decided
- May 14, 1998
- Review
- 211 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914085 (1991). 2 ancestors in all. 100 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
- This deviceK973920 StardustRespironics, Inc. · 1998
- Descendant · cites it directly · 69 of its ownK000253 Silent Night VSleep Solutions, Inc. · 2000
- Descendant · 2 generations on · 63 of its ownK042745 Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 53 of its ownK083325 N-600X with SPD, Oximax N-600XCovidien · 2009
- Descendant · 4 generations on · 49 of its ownK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
- Descendant · 4 generations on · 45 of its ownK121806 Beside Respiratory Patient Monitoring System Beside Resiratory…Covidien · 2012
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 100 · See all- K000253Silent Night VSleep Solutions, Inc. · 2000 · cites it directly69descendants
- K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · 2 generations on63descendants
- K083325N-600X with SPD, Oximax N-600XCovidien · 2009 · 3 generations on53descendants
- K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012 · 4 generations on49descendants
- K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien · 2012 · 4 generations on45descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991 | — |
| 0 (this device) | K973920 | Stardust | Respironics, Inc. | 1998 | — |
| +1 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| +2 | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | 1 |
| +3 | K083325 | N-600X with SPD, Oximax N-600X | Covidien | 2009 | — |
| +4 | K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0 | Covidien | 2012 | — |
| +4 | K121806 | Beside Respiratory Patient Monitoring System Beside Resiratory Patient… | Covidien | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 12 | 0 |
| 2023 | 1 | 0 |
| 2024 | 8 | 0 |
| 2025 | 12 | 0 |
| 2026 | 8 | 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? (2)
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 |
|---|---|---|---|
| * | K914620 | HMS-4000 Physiological Monitor, ModificationSummary page 1…sification Reference 21 CFR 870.2700 Common/Usual Name pulse oximeter Proprietary Name Stardust Internal Project Name One Night Stand (ONS) Predicate Devices HMS 4000 (K914620/A) Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA 15668 HMS 5000 (K914085) Respironics, Inc. 1001 Murry Ridge Drive… | 1992 |
| * | K914085 | HMS-5000Summary page 1…e Stardust Internal Project Name One Night Stand (ONS) Predicate Devices HMS 4000 (K914620/A) Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA 15668 HMS 5000 (K914085) Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA 15668 Reason for submission New Device Substantial Equivalence This… | 1991 |
What descends from it? (100)
See all 1003 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?
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 is indicated for use in the diagnosis of respiratory disorders, such as sleep apnea.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973920: Stardust.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973920
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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