# K222330: The Heart Seat

- Pathway: 510(k) (Traditional)
- Applicant: Casana Care, Inc.
- Decided: Apr 24, 2023 after 265 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K941811 (1994). 123 ancestors in all.
No later device cites it as a predicate yet.
1 of 124 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210086: Vitals360 Multi-Vitals Mobile Monitor, Vocare, Inc. (2021) Summary page 4.

## Indications for use
The Heart Seat is a replacement for a standard toilet seat that is indicated for use in a home environment. The Heart Seat is intended to be used for measuring, displaying, reviewing and storing non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) and heart rate (HR) in adults of at least 22 years of age with weight ranging from 90 to 350 pounds. Data from the Heart Seat are collected whenever the seat is used and are automatically uploaded to the Casana Cloud where they can be viewed by the healthcare provider. The Heart Seat is not intended for continuous monitoring.

Source page: https://510kreport.com/device/K222330
Methodology: https://510kreport.com/methodology