510(k) · Cleared
ClearedSomnolyzer 24X7
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 Oct 17, 2013 as substantially equivalent to K083620 (The Siesta Group North America, 2009) after a 111-day review. Its family tree reaches back 4 generations to 1987. 5 later devices descend from it.
- Decided
- Oct 17, 2013
- Review
- 111 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K873535 (1987). 5 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 3 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 2 generations backK022506 Morpheus 1, Automated Sleep Study Scoring & Data Management SystemWidemed, Ltd. · 2003
- 1 generation backK083620 Somnolyzer 24X7The Siesta Group North America · 2009
- This deviceK131994 Somnolyzer 24X7Respironics, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK142988 Sleepware G3Respironics, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK202142 Sleepware G3Respironics, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK241960 DeepRESPNox Medical Ehf · 2025
- Descendant · 2 generations on · 0 of its ownK250851 Hypnos (369054-200)Cadwell Industries, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK252330 DeepRESPNox Medical Ehf · 2025
Most influential descendants
Showing 5 of 5 · See all- K142988Sleepware G3Respironics, Inc. · 2015 · cites it directly4descendants
- K202142Sleepware G3Respironics, Inc. · 2020 · 2 generations on2descendants
- K241960DeepRESPNox Medical Ehf · 2025 · 3 generations on1descendant
- K250851Hypnos (369054-200)Cadwell Industries, Inc. · 2025 · 2 generations on0descendants
- K252330DeepRESPNox Medical Ehf · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −3 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −2 | K022506 | Morpheus 1, Automated Sleep Study Scoring & Data Management System | Widemed, Ltd. | 2003 | — |
| −1 | K083620 | Somnolyzer 24X7 | The Siesta Group North America | 2009 | — |
| 0 (this device) | K131994 | Somnolyzer 24X7 | Respironics, Inc. | 2013 | — |
| +1 | K142988 | Sleepware G3 | Respironics, Inc. | 2015 | — |
| +2 | K202142 | Sleepware G3 | Respironics, Inc. | 2020 | — |
| +3 | K241960 | DeepRESP | Nox Medical Ehf | 2025 | — |
| +2 | K250851 | Hypnos (369054-200) | Cadwell Industries, Inc. | 2025 | — |
| +4 | K252330 | DeepRESP | Nox Medical Ehf | 2025 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K083620 | Somnolyzer 24X7Summary page 1…Recorder Common/Usual Name Sleep Analysis System Proprietary Name Somnolyzer 24x7 Predicate Device(s) Somnolyzer 24x7 (K083620) Reason for submission Modified Device Substantial Equivalence The modified device has the following similar… | 2009 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142988 | Sleepware G3 | 2015 | 4 |
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 26 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K142988 (Respironics, Inc., 2015) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K083620.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 247 is a 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/K131994 · printed Nov 4, 2026
Cite this page
510(k) Report. “K131994: 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/K131994
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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