# K041724: Compass M10 System

- Pathway: 510(k) (Traditional)
- Applicant: Medcare Flaga
- Decided: Sep 28, 2004 after 96 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913396 (1992). 11 ancestors in all.
41 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024322: Embla N7000, Medcare Flaga (2003) Summary page 1.
- K962865: Rembrandt System, Airsep Corp. (1996) Summary page 1.
- K030379: Aplab, Model 801D0030, Sector Medical Corp. (2003) Summary page 1.

## Most influential descendants
- K061405: Apnealink, Model 22302 (2006), 30 descendants of its own
- K070263: Apnealink (2007), 29 descendants of its own
- K083575: Apnealink Plus, Model: 22328 (2009), 27 descendants of its own
- K082113: Nox T3, Noxturnal (PC Application) (2008), 17 descendants of its own
- K140124: S9 Elouera (2014), 8 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K041724
Methodology: https://510kreport.com/methodology