# K150614: Reveal LINQ

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Aug 6, 2015 after 149 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.
15 later devices descend from it; 2 cite it directly.
0 of 74 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
- K160809: Reveal LINQ (2016), 12 descendants of its own
- K162855: Reveal LINQ (2017), 11 descendants of its own
- K200795: LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit (2020), 9 descendants of its own
- K221962: LINQ II Insertable Cardiac Monitor (2022), 4 descendants of its own
- K233320: LINQ II™ Insertable Cardiac Monitor (LNQ22) (2023), 3 descendants of its own

## Indications for use
The Reveal LINQ ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in the following cases: • patients with clinical syndromes or situations at increased risk of cardiac arrhythmias • patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia The device has not been tested specifically for pediatric use.

Source page: https://510kreport.com/device/K150614
Methodology: https://510kreport.com/methodology