# K200884: B-Secur HeartKey Software Library

- Pathway: 510(k) (Traditional)
- Applicant: B-Secur, Ltd.
- Decided: Dec 7, 2020 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: 8 generations back to K963725 (1997). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181823: KardiaAI, AliveCor, Inc. (2019) Summary page 4.

## Indications for use
The B-Secur HeartKey Software Library is intended to be used by medical device manufacturers in medical devices to assess a single lead ECG spot checks from adult patients. The product allows the processing and extraction of beats from an ECG signal to provide a heart rate reading and ECG rhythm analysis. The library will classify a 30 second ECG spot check recording as normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia, unreadable or inconclusive. The library is intended to be integrated into other device software. All interpretations must be reviewed by a medical professional for clinical decision making, and the user of the device should not make changes to their medication without consulting a physician. The library is not intended for use in life supporting or sustaining systems, or cardiac alarm systems.

Source page: https://510kreport.com/device/K200884
Methodology: https://510kreport.com/methodology