510(k) · Cleared
ClearedSilent Night I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Local Silence, Inc. · MNR Ventilatory Effort Recorder
Cleared on Jan 23, 1997 as substantially equivalent to K910870 (Edentec Corp., 1991) after a 136-day review. Its family tree reaches back 1 generation to 1991. 97 later devices descend from it.
- Decided
- Jan 23, 1997
- Review
- 136 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910870 (1991). 97 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- This deviceK963597 Silent Night ILocal Silence, Inc. · 1997
- Descendant · cites it directly · 96 of its ownK981034 Silent Night IISleep Solutions, Inc. · 1998
- Descendant · 2 generations on · 69 of its ownK000253 Silent Night VSleep Solutions, Inc. · 2000
- Descendant · 3 generations on · 63 of its ownK042745 Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 53 of its ownK083325 N-600X with SPD, Oximax N-600XCovidien · 2009
- Descendant · 5 generations on · 49 of its ownK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 97 · See all- K981034Silent Night IISleep Solutions, Inc. · 1998 · cites it directly96descendants
- K000253Silent Night VSleep Solutions, Inc. · 2000 · 2 generations on69descendants
- K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · 3 generations on63descendants
- K083325N-600X with SPD, Oximax N-600XCovidien · 2009 · 4 generations on53descendants
- K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012 · 5 generations on49descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| 0 (this device) | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| +1 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| +2 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| +3 | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | 1 |
| +4 | K083325 | N-600X with SPD, Oximax N-600X | Covidien | 2009 | — |
| +5 | K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0 | Covidien | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K910870 | Edentec Model 3711 Digital RecorderSummary page 1…tory Effort Recorder (73 MNR) Legally Marketed Device to Which Equivalence is Claimed: The legally marketed predicate device is the EdenTec Model 3711 Digital Recorder (K910870), determined to be substantially equivalent to a legally marketed (preAmendment) device on August 29, 1991. The Silent Night I ha… | 1991 |
What descends from it? (97)
See all 971 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981034 | Silent Night II | 1998 | 96 |
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?
- Its one ancestor has no recall.
- Of its descendants, K981034 (Sleep Solutions, Inc., 1998) has gone furthest, with 96 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 1 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. The device is designed for use in home screening of adults with possible sleep disorders.
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/K963597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963597: Silent Night I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963597
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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