510(k) · Cleared
ClearedCompass F10 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 7, 2004 as substantially equivalent to K024322 (Medcare Flaga, 2003) and 2 other predicates after a 54-day review. Its family tree reaches back 4 generations to 1992. 54 later devices descend from it.
- Decided
- Sep 7, 2004
- Review
- 54 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. 54 later devices descend from it, 4 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 deviceK041904 Compass F10 SystemMedcare Flaga · 2004
- Descendant · cites it directly · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- Descendant · cites it directly · 27 of its ownK122516 Embletta MPREmbla Systems · 2013 · Recalled
- Descendant · 2 generations on · 20 of its ownK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- Descendant · 3 generations on · 12 of its ownK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
- Descendant · cites it directly · 10 of its ownK092062 Everon 1.0Earlysense, Ltd. · 2010
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K073682Embletta GoldEmbla Systems, Inc. · 2008 · cites it directly41descendants
- K122516Embletta MPREmbla Systems · 2013 · cites it directly27descendants
- K161579Watch-PAT200UItamar Medical, Ltd. · 2017 · 2 generations on20descendants
- K180775Watch-PAT300Itamar Medical, Ltd. · 2018 · 3 generations on12descendants
- K092062Everon 1.0Earlysense, Ltd. · 2010 · cites it directly10descendants
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) | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| +1 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| +1 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| +2 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| +3 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | — |
| +1 | K092062 | Everon 1.0 | Earlysense, Ltd. | 2010 | — |
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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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 Sect… | 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 Sidumuli 24… | 1996 |
| * | K030379 | Aplab, Model 801D0030Summary page 1…m from Medcare Flaga Product Code: FLS 510(k) Number: K962865 ApLab from Sector Medical Corp. Product Code: MNR 510(k) Number: K030379 Medcare Flaga Sidumuli 24 108 Reykjavik Iceland phone +354 510 2000 fax +354 510 2010 w ww reedcarepcorn… | 2003 |
What descends from it? (54)
See all 544 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, K073682 (Embla Systems, Inc., 2008) has gone furthest, with 41 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 F10 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 F10 device is intended to be used for adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041904: Compass F10 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041904
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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