# K230553: LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Apr 26, 2023 after 57 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: 15 generations back to K864889 (1987). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211304: LINQ II Insertable Cardiac Monitor, Medtronic, Inc. (2021) Summary page 4.

## 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 adult patients, and in pediatric patients who are at least 2 years old, 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

Source page: https://510kreport.com/device/K230553
Methodology: https://510kreport.com/methodology