# K182532: Liba3 System

- Pathway: 510(k) (Traditional)
- Applicant: National Cardiac, Inc.
- Decided: May 15, 2019 after 243 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K882803 (1988). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162956: Nowcardio System, Contex International Technologies (Canada), Inc. (2017) Summary page 4.

## Indications for use
The Liba3™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified Atrial Fibrillation Bradycardia Tachycardia Pause It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the Liba3™ will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG data are available to HealthCare Providers for analysis and reporting. Liba3™ js intended to be used with adult patients 22 years and older, but not designed for pediatric patients.

Source page: https://510kreport.com/device/K182532
Methodology: https://510kreport.com/methodology