# K252628: Cassie

- Pathway: 510(k) (Traditional)
- Applicant: Wesper, Inc.
- Decided: Apr 27, 2026 after 250 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: 9 generations back to K913396 (1992). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182618: SleepImage System, Mycardio, LLC Dba Sleepimage. (2019) Summary page 5.

## Indications for use
Cassie is a Software as a Medical Device (SaMD) that automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data, typically collected during sleep using compatible devices. Cassie is intended for use by and by order of a healthcare professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for adults. The Wesper Apnea Hypopnea Index (wAHI) and other outputs presented when oximeter data is available are intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The Cassie output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.

Source page: https://510kreport.com/device/K252628
Methodology: https://510kreport.com/methodology