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 Jan 9, 2012 as substantially equivalent to K111194 (Advanced Brain Monitoring, Inc., 2011) and 1 other predicate after a 132-day review. Its family tree reaches back 4 generations to 1987. 38 later devices descend from it.
- Decided
- Jan 9, 2012
- Review
- 132 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K873535 (1987). 17 ancestors in all. 38 later devices descend from it, 5 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 backK072014 VitascoreVitascore B.V. · 2007
- 1 generation backK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- This deviceK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- Descendant · cites it directly · 18 of its ownK120447 X4Advanced Brain Monitoring, Inc. · 2012
- Descendant · cites it directly · 17 of its ownK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- Descendant · cites it directly · 16 of its ownK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- Descendant · 2 generations on · 14 of its ownK131383 X10 Headset with X-Series Basic Software, X24 Headset with X-Series…Advanced Brain Monitoring, Inc. · 2013
- Descendant · cites it directly · 14 of its ownK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K120447X4Advanced Brain Monitoring, Inc. · 2012 · cites it directly18descendants
- K130013X4 SystemAdvanced Brain Monitoring, Inc. · 2013 · cites it directly17descendants
- K120450Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012 · cites it directly16descendants
- K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc. · 2013 · 2 generations on14descendants
- K130007Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013 · cites it directly14descendants
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 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| −1 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| 0 (this device) | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| +1 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| +1 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| +1 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| +2 | K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… | Advanced Brain Monitoring, Inc. | 2013 | — |
| +1 | K130007 | Sleep Profiler | 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 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 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? (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 |
|---|---|---|---|
| * | K111194 | Apnea Risk Evaluation System (Ares)Summary page 1…sk Evaluation System (ARESTM), Model 610 COMMON/USUAL NAME: ARES CLASSI FICATION NAM ES: 868.2375 Ventilatory Effort Recorder PRODUCT CODE: MNR PREDICATE DEVICE(S): K111194 Apnea Risk Evaluation System (ARES), Model 610 K(082968 ApneiCare Connection Center /Internet Analysis, ApneiCare, LLC === Page… | 2011 |
| * | K082968 | Apneicare Connection Center/Internet AnalysisSummary page 3…steep data over the internet (K082968). Derived a SpO2 Sp02 Equivalent. Improved filtering… | 2009 |
What descends from it? (38)
See all 385 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 25 years and passes through 5 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K120447 (Advanced Brain Monitoring, Inc., 2012) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K111194.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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/K112514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112514: 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/K112514
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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