# K151269: ECG Mini System Continuous ECG Monitor and Arrhythmia Detector

- Pathway: 510(k) (Traditional)
- Applicant: Lifewatch Technologies, Ltd.
- Decided: Jan 15, 2016 after 247 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: 6 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)
- K101639: CG-6108 Act-IL Continuous Ecg Monitor and Arrythmia Detector, Card Guard Scientific Survival, Ltd. (2010) Summary page 4.

## Indications for use
The ECG Mini System Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation. The device has not been tested for and it is not intended for pediatric use.

Source page: https://510kreport.com/device/K151269
Methodology: https://510kreport.com/methodology