510(k) · Cleared
ClearedCompumedics Somte PSG Recording System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumedics Limited · MNR Ventilatory Effort Recorder
Cleared on Apr 14, 2008 as substantially equivalent to K955841 (Compumedics Ptd, Ltd., 1997) and 1 other predicate after a 250-day review. Its family tree reaches back 2 generations to 1987. 48 later devices descend from it.
- Decided
- Apr 14, 2008
- Review
- 250 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K873535 (1987). 6 ancestors in all. 48 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 1 generation backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- This deviceK072201 Compumedics Somte PSG Recording SystemCompumedics Limited · 2008
- Descendant · cites it directly · 40 of its ownK111194 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · 2 generations on · 38 of its ownK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- Descendant · 3 generations on · 18 of its ownK120447 X4Advanced Brain Monitoring, Inc. · 2012
- Descendant · 3 generations on · 17 of its ownK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- Descendant · 3 generations on · 16 of its ownK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · cites it directly40descendants
- K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012 · 2 generations on38descendants
- K120447X4Advanced Brain Monitoring, Inc. · 2012 · 3 generations on18descendants
- K130013X4 SystemAdvanced Brain Monitoring, Inc. · 2013 · 3 generations on17descendants
- K120450Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −1 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| 0 (this device) | K072201 | Compumedics Somte PSG Recording System | Compumedics Limited | 2008 | — |
| +1 | K111194 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +2 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| +3 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| +3 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| +3 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K955841 | Sleep System for Clinics & ResearchSummary page 1…is substantially equivalent to: Device name: Compumedics Sleep Monitoring System Supplier: Compumedics Limited 510(k) number: K955841. Device name: Compumedics Somt6 Recording System Supplier: Compumedics Limited 510(k) number:… | 1997 |
| * | K021176 | Compumedics Somte SystemSummary page 1…mited 510(k) number: K955841. Device name: Compumedics Somt6 Recording System Supplier: Compumedics Limited 510(k) number: K021176. 3. Description of the Device The Somt6 PSG System comprises hardware and software which provides up to 27 separ… | 2003 |
What descends from it? (48)
See all 483 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 21 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K111194 (Advanced Brain Monitoring, Inc., 2011) has gone furthest, with 40 descendants of its own.
- 4 other devices also cite its predicate K955841.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The Somt6 PSG is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders.
The Somt6 PSG is designed for ambulatory and mobile operation and can be used in either the patient's home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible.
The SomtM PSG is only to be used under the direction of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072201: Compumedics Somte PSG Recording System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072201
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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