# K182618: SleepImage System

- Pathway: 510(k) (Traditional)
- Applicant: Mycardio, LLC Dba Sleepimage.
- Decided: Aug 14, 2019 after 324 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: 8 generations back to K913396 (1992). 29 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K163696: SleepImage System, Mycardio, LLC Dba Sleepimage. (2017) Summary page 4.

## Most influential descendants
- K252628: Cassie (2026), 0 descendants of its own
- K231355: Aurora (2024), 0 descendants of its own

## Indications for use
The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for children, adolescents and adults. The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.

Source page: https://510kreport.com/device/K182618
Methodology: https://510kreport.com/methodology