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 Oct 14, 2004 after a 118-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 44 later devices descend from it.
- Decided
- Oct 14, 2004
- Review
- 118 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 1 citing it directly.
- This deviceK041662 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2004
- Descendant · cites it directly · 43 of its ownK071230 Apnea Risk Evaluation System (Ares), Model 600Advanced Brain Monitoring, Inc. · 2007
- Descendant · 2 generations on · 41 of its ownK110705 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · 3 generations on · 40 of its ownK111194 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · 4 generations on · 38 of its ownK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- Descendant · 5 generations on · 18 of its ownK120447 X4Advanced Brain Monitoring, Inc. · 2012
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K071230Apnea Risk Evaluation System (Ares), Model 600Advanced Brain Monitoring, Inc. · 2007 · cites it directly43descendants
- K110705Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · 2 generations on41descendants
- K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · 3 generations on40descendants
- K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012 · 4 generations on38descendants
- K120447X4Advanced Brain Monitoring, Inc. · 2012 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041662 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2004 | — |
| +1 | K071230 | Apnea Risk Evaluation System (Ares), Model 600 | Advanced Brain Monitoring, Inc. | 2007 | — |
| +2 | K110705 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +3 | K111194 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +4 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| +5 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (44)
See all 441 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071230 | Apnea Risk Evaluation System (Ares), Model 600 | 2007 | 43 |
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?
- Of its descendants, K071230 (Advanced Brain Monitoring, Inc., 2007) has gone furthest, with 43 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.
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 | — |
https://510kreport.com/device/K041662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041662: 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/K041662
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026