# K193473: LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jun 26, 2020 after 193 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: 10 generations back to K864889 (1987). 58 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132649: Reveal Linq Insertable Cardiac Monitor, Medtronic, Inc. (2014) Summary page 4.

## Most influential descendants
- K231328: LUX-Dx II (M302); LUX-Dx II+ (M312) (2023), 1 descendant of its own
- K252593: LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) (2025), 0 descendants of its own
- K210608: LUX-Dx Insertable Cardiac Monitor (2021), 0 descendants of its own

## Indications for use
The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous ECG (S-ECG) for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition, are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a heart condition 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/K193473
Methodology: https://510kreport.com/methodology