# K171816: Kardia Band System

- Pathway: 510(k) (Traditional)
- Applicant: AliveCor, Inc.
- Decided: Nov 16, 2017 after 150 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- 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.
12 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142743: AliveCor Heart Monitor, AliveCor, Inc. (2015) Summary page 4.

## Most influential descendants
- K181823: KardiaAI (2019), 6 descendants of its own
- K183319: Triangle System (2019), 3 descendants of its own
- K182456: Study Watch (2019), 3 descendants of its own
- K210753: KardiaMobile 6L (2021), 2 descendants of its own
- K192415: Study Watch with Irregular Pulse Monitor (2020), 2 descendants of its own

## Indications for use
The Kardia Band System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Kardia Band System also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The Kardia Band System is intended for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.

Source page: https://510kreport.com/device/K171816
Methodology: https://510kreport.com/methodology