# K211304: LINQ II Insertable Cardiac Monitor

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: May 28, 2021 after 29 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: 14 generations back to K864889 (1987). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200795: LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit, Medtronic, Inc. (2020) Summary page 4.

## Most influential descendants
- K230553: LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application (2023), 0 descendants of its own

## Recalls of this device
- Nov 3, 2023 · Class II · Z-0421-2024: It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasion

## Indications for use
The LINQ II 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/K211304
Methodology: https://510kreport.com/methodology