# K232445: CSF-4 (CSF-4)

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacsense
- Decided: May 2, 2024 after 262 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K962603 (1997). 126 ancestors in all.
No later device cites it as a predicate yet.
1 of 127 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221260: CSF-3, Cardiacsense (2023) Summary page 5.
- K181352: Loop System, Spry Health, Inc. (2019) Summary page 5.

## Indications for use
The CSF-4 is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The ECG signal is for quality checks of the data and for manual interpretation of heart rate. The CSF-4 also measures, records and displays pulse rate. The CSF-4 is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2). The CSF-4 is for adult patients and health-conscious individuals in hospitals, clinics, long-term care facilities, and homes. The CSF-4 is a prescription device and should be used under the care of a physician. CSF-4 does not provide any alarms. It is not intended for pediatric use or use in critical care settings. The device is not intended to provide outputs during periods of motion.

Source page: https://510kreport.com/device/K232445
Methodology: https://510kreport.com/methodology