510(k) · Cleared
ClearedSomnolyzer 24X7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Siesta Group North America · MNR Ventilatory Effort Recorder
Cleared on Mar 6, 2009 as substantially equivalent to K022506 (Widemed, Ltd., 2003) after an 88-day review. Its family tree reaches back 3 generations to 1987. 25 later devices descend from it.
- Decided
- Mar 6, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K873535 (1987). 4 ancestors in all. 25 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 2 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 1 generation backK022506 Morpheus 1, Automated Sleep Study Scoring & Data Management SystemWidemed, Ltd. · 2003
- This deviceK083620 Somnolyzer 24X7The Siesta Group North America · 2009
- Descendant · cites it directly · 18 of its ownK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- Descendant · 2 generations on · 16 of its ownK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- Descendant · 3 generations on · 14 of its ownK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
- Descendant · 4 generations on · 13 of its ownK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
- Descendant · 5 generations on · 9 of its ownK162627 EnsoSleepEnsodata, Inc. · 2017
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K112102Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011 · cites it directly18descendants
- K120450Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012 · 2 generations on16descendants
- K130007Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013 · 3 generations on14descendants
- K153412Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016 · 4 generations on13descendants
- K162627EnsoSleepEnsodata, Inc. · 2017 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −2 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −1 | K022506 | Morpheus 1, Automated Sleep Study Scoring & Data Management System | Widemed, Ltd. | 2003 | — |
| 0 (this device) | K083620 | Somnolyzer 24X7 | The Siesta Group North America | 2009 | — |
| +1 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| +2 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| +3 | K130007 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2013 | — |
| +4 | K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016 | — |
| +5 | K162627 | EnsoSleep | Ensodata, Inc. | 2017 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K022506 | Morpheus 1, Automated Sleep Study Scoring & Data Management SystemSummary page 1…Vienna 1210 Austria Predicate Devices Morpheus TM 1, Automated Sleep Study Scoring and Data System by Widemed, Ltd. cleared under 510(k) #K022506. The Siesta Group - Somnolyzer 24x7 510(k) Submission… | 2003 |
What descends from it? (25)
See all 252 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 22 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K112102 (Younes Sleep Technologies, 2011) has gone furthest, with 18 descendants of its own.
- 2 other devices also cite its predicate K022506.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
somnolyzer 24X7 isa computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.
Somnolyzer 24X7 is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.
This device is to be used under the supervision of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083620 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083620: Somnolyzer 24X7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083620
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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