# K200795: LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jul 3, 2020 after 99 days
- Product code: MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K864889 (1987). 61 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162855: Reveal LINQ, Medtronic, Inc. (2017) Summary page 4.
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539), Medtronic, Inc. (2007) Summary page 4.

## Most influential descendants
- K221962: LINQ II Insertable Cardiac Monitor (2022), 4 descendants of its own
- K233320: LINQ II™ Insertable Cardiac Monitor (LNQ22) (2023), 3 descendants of its own
- K240693: LINQ II™ Insertable Cardiac Monitor (ICM) (2024), 1 descendant of its own
- K210484: LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System (2021), 1 descendant of its own
- K211304: LINQ II Insertable Cardiac Monitor (2021), 1 descendant 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
- Jan 18, 2022 · Class II · Z-0782-2022: Devices may lose functionality due to susceptibility to moisture ingress.
- May 14, 2021 · Class II · Z-2076-2021: Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.

## 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/K200795
Methodology: https://510kreport.com/methodology