# K181998: CardioBand ECG Event Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Strategy and Innovation Center (Ssic)
- Decided: Nov 15, 2018 after 112 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: 7 generations back to K963725 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171816: Kardia Band System, AliveCor, Inc. (2017) Summary page 4.

## Indications for use
The CardioBand Event Recorder is indicated for use by adult patients, when prescribed by a physician, to record, display, store and transfer single-channel electrocardiogram (ECG) for rhythm interpretation.

Source page: https://510kreport.com/device/K181998
Methodology: https://510kreport.com/methodology