# K162855: Reveal LINQ

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Feb 23, 2017 after 134 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: 12 generations back to K864889 (1987). 60 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160809: Reveal LINQ, Medtronic, Inc. (2016) Summary page 4.

## Most influential descendants
- K200795: LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit (2020), 9 descendants of its own
- 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

## Recalls of this device
- Jun 1, 2021 · Class II · Z-2102-2021: Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.

## Indications for use
The Reveal LINQ 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/K162855
Methodology: https://510kreport.com/methodology