510(k) · Cleared
ClearedCompass M10 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcare Flaga · MNR Ventilatory Effort Recorder
Cleared on Sep 28, 2004 as substantially equivalent to K024322 (Medcare Flaga, 2003) and 2 other predicates after a 96-day review. Its family tree reaches back 4 generations to 1992. 41 later devices descend from it.
- Decided
- Sep 28, 2004
- Review
- 96 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K913396 (1992). 11 ancestors in all. 41 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 3 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 2 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 1 generation backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- This deviceK041724 Compass M10 SystemMedcare Flaga · 2004
- Descendant · cites it directly · 30 of its ownK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- Descendant · 2 generations on · 29 of its ownK070263 ApnealinkResmed Germany, Inc. · 2007
- Descendant · 3 generations on · 27 of its ownK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- Descendant · cites it directly · 17 of its ownK082113 Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · Recalled
- Descendant · 4 generations on · 8 of its ownK140124 S9 EloueraResmed Corp · 2014
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K061405Apnealink, Model 22302Resmed Germany, Inc. · 2006 · cites it directly30descendants
- K070263ApnealinkResmed Germany, Inc. · 2007 · 2 generations on29descendants
- K083575Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009 · 3 generations on27descendants
- K082113Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · cites it directly17descendants
- K140124S9 EloueraResmed Corp · 2014 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −3 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −2 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −1 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| 0 (this device) | K041724 | Compass M10 System | Medcare Flaga | 2004 | — |
| +1 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| +2 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| +3 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| +1 | K082113 | Nox T3, Noxturnal (PC Application) | Nox Medical | 2008 | 1 |
| +4 | K140124 | S9 Elouera | Resmed Corp | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K024322 | Embla N7000Summary page 1…s II Classification Panel: Anesthesiology Predicate Devices Embla N7000 from Medcare Flaga Product Code: MNR 510(k) Number: K024322 Rembrandt System from Medcare Flaga Product Code: FLS 510(k) Number: K962865 ApLab from Sec… | 2003 |
| * | K962865 | Rembrandt SystemSummary page 1…Medcare Flaga Product Code: MNR 510(k) Number: K024322 Rembrandt System from Medcare Flaga Product Code: FLS 510(k) Number: K962865 ApLab from Sector Medical Corp. Product Code: MNR 510(k) Number: K030379 Medcare Flaga u Sidumuli… | 1996 |
| * | K030379 | Aplab, Model 801D0030Summary page 1…rom Medcare Flaga Product Code: FLS 510(k) Number: K962865 ApLab from Sector Medical Corp. Product Code: MNR 510(k) Number: K030379 Medcare Flaga u Sidumuli 24 s 108 Reykjavik · Iceland · phone +354 510 2000 tfax +354 510 2010 s mwtwmedcarercoM… | 2003 |
What descends from it? (41)
See all 412 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 12 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K061405 (Resmed Germany, Inc., 2006) has gone furthest, with 30 descendants of its own.
- 4 other devices also cite its predicate K024322.
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 | — |
What is it indicated for?
The intended use of the Compass M1o system is to record physiological signals during sleep, scan the signals for abnormalities and represent the count of abnormal events in a form of a summary report. The results of the scan may be manually overwritten or corrected by the physician. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's count of abnormal events. It is not intended for any diagnosis. It is not intended to be a monitor.
The Compass M10 system is intended to be used for adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041724: Compass M10 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041724
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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