510(k) · Cleared
ClearedSilent Night II
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 Oct 30, 1998 as substantially equivalent to K963597 (Local Silence, Inc., 1997) and 1 other predicate after a 225-day review. Its family tree reaches back 2 generations to 1991. 96 later devices descend from it.
- Decided
- Oct 30, 1998
- Review
- 225 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910870 (1991). 3 ancestors in all. 96 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 1 generation backK963597 Silent Night ILocal Silence, Inc. · 1997
- This deviceK981034 Silent Night IISleep Solutions, 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 96 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 96 · 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 |
|---|---|---|---|---|---|
| −2 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −1 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| 0 (this device) | K981034 | Silent Night II | Sleep Solutions, 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 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 15 | 0 |
| 2023 | 4 | 0 |
| 2024 | 8 | 0 |
| 2025 | 14 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K963597 | Silent Night ISummary page 1…: Ventilatory Effort Recorder (73 MNR); Class 11 Legally Marketed Devices to which Equivalence is Claimed: The legally marketed predicate device is the Silent Night™ I (K963597), determined to be substantially equivalent to a legally marketed (preAmendment) device on January 23, 1997. The Silent Night II… | 1997 |
| * | K915856 | Sensormedics 4000 Series Sleep SystemSummary page 1…dment) device on January 23, 1997. The Silent Night II was evaluated in the clinical setting in comparison to the legally marketed Sensormedics 4000 Series Sleep System (K915856), determined to be substantially equivalent to a legally marketed (preAmendment) device on October 26, 1992. Device Description:… | 1992 |
What descends from it? (96)
See all 962 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 7 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K000253 (Sleep Solutions, Inc., 2000) has gone furthest, with 69 descendants of its own.
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 Silent Night II is indicated for use in the diagnostic evaluation of adults with possible Obstructive Sleep Apnea. It is intended to record a patient's respiratory pattern during sleep. The device is designed for prescription use in home screening of adults with possible sleep disorders. Information provided by the device includes the numbers of apneic and hypopneic events and the proportion of these events to the total sleep duration; and snoring levels (in decibels). The device is capable of recording four nights or up to 40 hours for an individual patient, after which time the sleep data are downloaded for provision to the prescribing physician.
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/K981034 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981034: Silent Night II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981034
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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