# K210608: LUX-Dx Insertable Cardiac Monitor

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: May 25, 2021 after 85 days
- Product code: MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection))
- 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: 11 generations back to K864889 (1987). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193473: LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US, Boston Scientific Corporation (2020) Summary page 4.

## Indications for use
The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECG). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rthythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath. The LUX-Dx has not been tested specifically for pediatric use.

Source page: https://510kreport.com/device/K210608
Methodology: https://510kreport.com/methodology