# K262735: LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Aug 28, 2026 after 28 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: 17 generations back to K864889 (1987). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240693: LINQ II™ Insertable Cardiac Monitor (ICM), Medtronic, Inc. (2024) Summary page 5.

## 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 -patients who have been previously diagnosed with or treated for atrial or ventricular arrhythmias

Source page: https://510kreport.com/device/K262735
Methodology: https://510kreport.com/methodology