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 Apr 14, 2011 as substantially equivalent to K071230 (Advanced Brain Monitoring, Inc., 2007) after a 31-day review. Its family tree reaches back 2 generations to 2001. 41 later devices descend from it.
- Decided
- Apr 14, 2011
- Review
- 31 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003154 (2001). 4 ancestors in all. 41 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003154 Mizar, Basis BE, Sandman DigitalEb Neuro S.P.A. · 2001
- 1 generation backK071230 Apnea Risk Evaluation System (Ares), Model 600Advanced Brain Monitoring, Inc. · 2007
- This deviceK110705 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- 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 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · 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 | K003154 | Mizar, Basis BE, Sandman Digital | Eb Neuro S.P.A. | 2001 | — |
| −1 | K071230 | Apnea Risk Evaluation System (Ares), Model 600 | Advanced Brain Monitoring, Inc. | 2007 | — |
| 0 (this device) | K110705 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +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 |
|---|---|---|
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 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? (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 |
|---|---|---|---|
| * | K071230 | Apnea Risk Evaluation System (Ares), Model 600Summary page 1…k Evaluation System (ARES TM), Model 610 COMMON/USUIAL NAME: ARES CLASSIFICATION NAM ES: 868.2375 Ventilatory Effort Recorder PRODUCT CODE: MNR PREDICATE DEVICE(S): K071230 Apnea Risk Evaluation System (ARES), Model 600… | 2007 |
What descends from it? (41)
See all 411 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111194 | Apnea Risk Evaluation System (Ares) | 2011 | 40 |
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 10 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K111194 (Advanced Brain Monitoring, Inc., 2011) has gone furthest, with 40 descendants of its own.
- 1 other device also cites its predicate K071230.
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/K110705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110705: 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/K110705
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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