510(k) · Decided
DecidedSleep System for Clinics & Research
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumedics Ptd, Ltd. · MNR Ventilatory Effort Recorder
Cleared on Mar 11, 1997 as substantially equivalent to K873535 (Nicolet Biomedical Instruments, 1987) and 1 other predicate after a 445-day review. Its family tree reaches back 1 generation to 1987. 63 later devices descend from it.
- Decided
- Mar 11, 1997
- Review
- 445 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K873535 (1987). 2 ancestors in all. 63 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- This deviceK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- Descendant · cites it directly · 48 of its ownK072201 Compumedics Somte PSG Recording SystemCompumedics Limited · 2008
- Descendant · 2 generations on · 40 of its ownK111194 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · cites it directly · 40 of its ownK072014 VitascoreVitascore B.V. · 2007
- Descendant · 2 generations on · 39 of its ownK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- Descendant · 3 generations on · 38 of its ownK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K072201Compumedics Somte PSG Recording SystemCompumedics Limited · 2008 · cites it directly48descendants
- K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · 2 generations on40descendants
- K072014VitascoreVitascore B.V. · 2007 · cites it directly40descendants
- K082968Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009 · 2 generations on39descendants
- K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012 · 3 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| 0 (this device) | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| +1 | K072201 | Compumedics Somte PSG Recording System | Compumedics Limited | 2008 | — |
| +2 | K111194 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +1 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| +2 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| +3 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 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 |
|---|---|---|
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K873535 | Nicolet Expert Sleep/Wake Analysis SystemSummary page 3…5, December 20, 1979 ( determination) and Somnitec Incorporated’s Somnimic (K912817, July 26, 1991, determination). Additionally, the Nicolet Expert Sleep/Wake System (K873535) and the SensorMedics Series 4000 Sleep System (K915856) have been cleared for commercial distribution through the determination… | 1987 |
| * | K915856 | Sensormedics 4000 Series Sleep SystemSummary page 3…rporated’s Somnimic (K912817, July 26, 1991, determination). Additionally, the Nicolet Expert Sleep/Wake System (K873535) and the SensorMedics Series 4000 Sleep System (K915856) have been cleared for commercial distribution through the determination of substantial equivalence under the 84GWQ product code… | 1992 |
What descends from it? (63)
See all 635 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?
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 Compumedics Sleep Monitoring System is used as an aid in the diagnosis of sleep and respiratory related sleep disorders. The use of this sleep monitoring system is to be under the supervision of a physician, sleep technologist or clinician. The Compumedics Sleep Monitoring System is an information management tool to record, display, organise, summarise, redisplay (retrieve) and generate user-defined reports based on the subject’s data received from…
Read the full statement (110 words)
The Compumedics Sleep Monitoring System is used as an aid in the diagnosis of sleep and respiratory related sleep disorders. The use of this sleep monitoring system is to be under the supervision of a physician, sleep technologist or clinician. The Compumedics Sleep Monitoring System is an information management tool to record, display, organise, summarise, redisplay (retrieve) and generate user-defined reports based on the subject’s data received from monitoring devices typically used to evaluate sleep and sleep related respiratory disorders.
The users of the Compumedics Sleep Monitoring System are medical professionals who have received training in the areas of hospital procedures, physiological monitoring of human subjects, and sleep disorder investigation.
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/K955841 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955841: Sleep System for Clinics & Research.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955841
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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