510(k) · Cleared
ClearedApnea Risk Evaluation System (Ares)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Brain Monitoring, Inc. · MNR Ventilatory Effort Recorder
Cleared on Jul 7, 2011 as substantially equivalent to K110705 (Advanced Brain Monitoring, Inc., 2011) and 2 other predicates after a 70-day review. Its family tree reaches back 3 generations to 1987. 40 later devices descend from it.
- Decided
- Jul 7, 2011
- Review
- 70 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K873535 (1987). 13 ancestors in all. 40 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 backK072201 Compumedics Somte PSG Recording SystemCompumedics Limited · 2008
- This deviceK111194 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · cites it directly · 38 of its ownK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- Descendant · 2 generations on · 18 of its ownK120447 X4Advanced Brain Monitoring, Inc. · 2012
- Descendant · 2 generations on · 17 of its ownK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- Descendant · 2 generations on · 16 of its ownK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- Descendant · 3 generations on · 14 of its ownK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012 · cites it directly38descendants
- K120447X4Advanced Brain Monitoring, Inc. · 2012 · 2 generations on18descendants
- K130013X4 SystemAdvanced Brain Monitoring, Inc. · 2013 · 2 generations on17descendants
- K120450Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012 · 2 generations on16descendants
- K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc. · 2013 · 3 generations on14descendants
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 | K072201 | Compumedics Somte PSG Recording System | Compumedics Limited | 2008 | — |
| 0 (this device) | K111194 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +1 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| +2 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| +2 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| +2 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| +3 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K110705 | Apnea Risk Evaluation System (Ares)Summary page 3…Evaluation System (ARE STM), Model 610 with the chest belt has the same indications for use and uses the same fundamental technology as the ARE STM Model 610 cleared via K110705. The AREST Model 610 with Respiratory Effort Belt is identical to the predicate ARE STM Model 610 without chest belt with the fol… | 2011 |
| * | K090484 | Alice PDXSummary page 3…asal Cannula a Nasal Cannula similarly to Respironics * Nasal pressure * Nasal pressure Alice POX (K090484) and transducer transducer Conipumnedics Somt6 * 3D… | 2009 |
| * | K072201 | Compumedics Somte PSG Recording SystemSummary page 3…transducer transducer Conipumnedics Somt6 * 3D accelerometers 0 3D accelerometers (K072201). " FF6 sensor * FF6 sensor (optional… | 2008 |
| † | K071230 | Apnea Risk Evaluation System (Ares), Model 600 | 2007 |
| † | K021176 | Compumedics Somte System | 2003 |
What descends from it? (40)
See all 402 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 24 years and passes through 4 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K112514 (Advanced Brain Monitoring, Inc., 2012) has gone furthest, with 38 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. 2011, 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 Apnea Risk Evaluation System (ARES), Model 610 is indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea. The ARES can record and score respiratory events during sleep (e.g., apneas, hypopneas, mixed apneas and flow limiting events). The device is designed for prescription use in home diagnosis of adults with possible sleep-related breathing disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111194: Apnea Risk Evaluation System (Ares).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111194
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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