# K092003: CPC Sleep Data Recorder, Model M1, and Application Software

- Pathway: 510(k) (Traditional)
- Applicant: MyCardio, LLC
- Decided: Sep 30, 2009 after 90 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: 6 generations back to K913396 (1992). 27 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073682: Embletta Gold, Embla Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K163696: SleepImage System (2017), 3 descendants of its own
- K182618: SleepImage System (2019), 2 descendants of its own
- K252628: Cassie (2026), 0 descendants of its own
- K231355: Aurora (2024), 0 descendants of its own

## Indications for use
The M1 sleep data recording device is intended for use by a physician or a trained technician for the collection of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep that will be used for screening different sleep associated disorders. The intended environment is any dry space used for sleeping. The CPC application software (and associated modules) is intended for use by a physician or a trained technician for the analysis, manipulation and final presentation of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep. The intended environment is any dry space suitable for the operation of a conventional computer. The device and software do not monitor or diagnose the patient and do not issue any alarms.

Source page: https://510kreport.com/device/K092003
Methodology: https://510kreport.com/methodology