# K221260: CSF-3

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacsense
- Decided: Jan 6, 2023 after 249 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: 6 generations back to K963725 (1997). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201456: Scan Monitor, Withings SA (2021) Summary page 4.

## Most influential descendants
- K232445: CSF-4 (CSF-4) (2024), 0 descendants of its own

## Indications for use
The CSF-3 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-3 is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2). The CSF-3 is for adult patients and health-conscious individuals in hospitals, clinics, long-term care facilities, and homes. The CSF-3 is a prescription device and should be used under the care of a physician. CSF-3 does not provide any alarms. It is not intended for pediatric use or use in critical care settings.

Source page: https://510kreport.com/device/K221260
Methodology: https://510kreport.com/methodology