510(k) · Cleared
ClearedApnea Risk Evaluation System (Ares), Model 600
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 Oct 3, 2007 as substantially equivalent to K041662 (Advanced Brain Monitoring, Inc., 2004) and 2 other predicates after a 153-day review. Its family tree reaches back 1 generation to 2001. 43 later devices descend from it.
- Decided
- Oct 3, 2007
- Review
- 153 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K003154 (2001). 3 ancestors in all. 43 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003154 Mizar, Basis BE, Sandman DigitalEb Neuro S.P.A. · 2001
- This deviceK071230 Apnea Risk Evaluation System (Ares), Model 600Advanced Brain Monitoring, Inc. · 2007
- Descendant · cites it directly · 41 of its ownK110705 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · 2 generations on · 40 of its ownK111194 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · 3 generations on · 38 of its ownK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- Descendant · 4 generations on · 18 of its ownK120447 X4Advanced Brain Monitoring, Inc. · 2012
- Descendant · 4 generations on · 17 of its ownK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K110705Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · cites it directly41descendants
- K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · 2 generations on40descendants
- K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012 · 3 generations on38descendants
- K120447X4Advanced Brain Monitoring, Inc. · 2012 · 4 generations on18descendants
- K130013X4 SystemAdvanced Brain Monitoring, Inc. · 2013 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003154 | Mizar, Basis BE, Sandman Digital | Eb Neuro S.P.A. | 2001 | — |
| 0 (this device) | K071230 | Apnea Risk Evaluation System (Ares), Model 600 | Advanced Brain Monitoring, Inc. | 2007 | — |
| +1 | K110705 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +2 | K111194 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +3 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| +4 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| +4 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
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 | 3 | 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? (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 |
|---|---|---|---|
| * | K041662 | Apnea Risk Evaluation System (Ares)Summary page 1…ate classification panel Anesthesiology Product code MNR Predicate Devices Advanced Brain Monitoring ARES (Model 500)(K041662) Sandman Digital (K003154), WatchPat 100S (K042916) Reason for submission… | 2004 |
| * | K003154 | Mizar, Basis BE, Sandman DigitalSummary page 1…MNR Predicate Devices Advanced Brain Monitoring ARES (Model 500)(K041662) Sandman Digital (K003154), WatchPat 100S (K042916) Reason for submission Modified design Substantial Equivalence Design verifica… | 2001 |
| * | K042916 | Watch Pat 100SSummary page 1…Predicate Devices Advanced Brain Monitoring ARES (Model 500)(K041662) Sandman Digital (K003154), WatchPat 100S (K042916) Reason for submission Modified design Substantial Equivalence Design verification and validation tests… | 2004 |
What descends from it? (43)
See all 432 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K110705 (Advanced Brain Monitoring, Inc., 2011) has gone furthest, with 41 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. 2007, 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) 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/K071230 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071230: Apnea Risk Evaluation System (Ares), Model 600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071230
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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