# K233320: LINQ II™ Insertable Cardiac Monitor (LNQ22)

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Oct 31, 2023 after 32 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.
3 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221962: LINQ II Insertable Cardiac Monitor, Medtronic, Inc. (2022) Summary page 5.

## Most influential descendants
- K240693: LINQ II™ Insertable Cardiac Monitor (ICM) (2024), 1 descendant of its own
- K262735: LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) (2026), 0 descendants of its own
- K233562: LINQ II Insertable Cardiac Monitor (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 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/K233320
Methodology: https://510kreport.com/methodology