# K163696: SleepImage System

- Pathway: 510(k) (Traditional)
- Applicant: Mycardio, LLC Dba Sleepimage.
- Decided: Oct 13, 2017 after 288 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: 7 generations back to K913396 (1992). 28 ancestors in all.
3 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)
- K092003: CPC Sleep Data Recorder, Model M1, and Application Software, MyCardio, LLC (2009) Summary page 4.

## Most influential descendants
- 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 SleepImage System is medical software that establishes sleep quality. The SleepImage system analyzes, displays and summarizes ECG data, typically collected during sleep that is intended for use by or on the order of a Health Care Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management.

Source page: https://510kreport.com/device/K163696
Methodology: https://510kreport.com/methodology