# K212008: Reveal LINQ Insertable Cardiac Monitor

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jul 22, 2021 after 24 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: 13 generations back to K864889 (1987). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162855: Reveal LINQ, Medtronic, Inc. (2017) Summary page 4.

## 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/K212008
Methodology: https://510kreport.com/methodology