510(k) · Cleared
ClearedSilent Night V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleep Solutions, Inc. · MNR Ventilatory Effort Recorder
Cleared on Nov 16, 2000 as substantially equivalent to K981034 (Sleep Solutions, Inc., 1998) and 2 other predicates after a 294-day review. Its family tree reaches back 3 generations to 1991. 69 later devices descend from it.
- Decided
- Nov 16, 2000
- Review
- 294 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K910870 (1991). 7 ancestors in all. 69 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 2 generations backK963597 Silent Night ILocal Silence, Inc. · 1997
- 1 generation backK981034 Silent Night IISleep Solutions, Inc. · 1998
- This deviceK000253 Silent Night VSleep Solutions, Inc. · 2000
- Descendant · cites it directly · 63 of its ownK042745 Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 53 of its ownK083325 N-600X with SPD, Oximax N-600XCovidien · 2009
- Descendant · 3 generations on · 49 of its ownK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
- Descendant · 3 generations on · 45 of its ownK121806 Beside Respiratory Patient Monitoring System Beside Resiratory…Covidien · 2012
- Descendant · 4 generations on · 40 of its ownK130320 Bedside Respiratory Patient Monitoring System, Bedside Respiratory…Covidien · 2014
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · cites it directly63descendants
- K083325N-600X with SPD, Oximax N-600XCovidien · 2009 · 2 generations on53descendants
- K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012 · 3 generations on49descendants
- K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien · 2012 · 3 generations on45descendants
- K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien · 2014 · 4 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −2 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| −1 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| 0 (this device) | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| +1 | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | 1 |
| +2 | K083325 | N-600X with SPD, Oximax N-600X | Covidien | 2009 | — |
| +3 | K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0 | Covidien | 2012 | — |
| +3 | K121806 | Beside Respiratory Patient Monitoring System Beside Resiratory Patient… | Covidien | 2012 | — |
| +4 | K130320 | Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient… | Covidien | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 11 | 0 |
| 2023 | 1 | 0 |
| 2024 | 7 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K981034 | Silent Night IISummary page 1…me: Ventilatory effort recorder (MNR) Class 11 Legally Marketed Devices to Which Equivalence is Claimed: The legally marketed predicate devices arc the Silent Night I (K981034), the Stardust (K973902), the EdenTrace M and the SensorMedics 4000 Series (K915856). The Silcnt Night v was cvalaated in the cli… | 1998 |
| * | K973920 | Stardust Our OCR of the scanned summary read K973902, FDA’s number for Vinyl Patient Examination Gloves Powdered (Everrise Glove Products Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Stardust”. | 1998 |
| * | K915856 | Sensormedics 4000 Series Sleep SystemSummary page 1…quivalence is Claimed: The legally marketed predicate devices arc the Silent Night I (K981034), the Stardust (K973902), the EdenTrace M and the SensorMedics 4000 Series (K915856). The Silcnt Night v was cvalaated in the clinical setting in comparison to the legally marketed SensorMedics 4000 Series sleep s… | 1992 |
| * | — | EdenTrace M Named without a submission number |
What descends from it? (69)
See all 693 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 9 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K042745 (Del Mar Reynolds Medical, Inc., 2005) has gone furthest, with 63 descendants of its own.
- 1 other device also cites its predicate K981034.
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 Slient Night V is indicated for use in the diagnostic evaluation of adults with possible sleep apnea. The Silent Night V can score obstructive apneas, which includes mixed apneas.
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/K000253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000253: Silent Night V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000253
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026