# K132649: Reveal Linq Insertable Cardiac Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Feb 14, 2014 after 172 days
- Product code: MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K864889 (1987). 57 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539), Medtronic, Inc. (2007) Summary page 1.
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538, Medtronic, Inc. (2007) Summary page 1.
- K103764: Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528, Medtronic, Inc. (2011) Summary page 1.
- K020825: King of Hearts Express + AF Monitor, Card Guard Scientific Survival, Ltd. (2002) Summary page 1.

## Most influential descendants
- K150614: Reveal LINQ (2015), 15 descendants of its own
- 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

## Recalls of this device
- Feb 23, 2016 · Class II · Z-1249-2016: Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery ca

## Indications for use
The Reveal LINQ Insertable Cardiac Monitor is an implantable patient-activated and automatically-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 Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management features in the Reveal LINQ ICM to initiate recording of cardiac event data in the implanted device memory.

Source page: https://510kreport.com/device/K132649
Methodology: https://510kreport.com/methodology