LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)— 510(k) K262735

Name: FDA 510(k) clearance K262735
Creator: U.S. Food and Drug Administration
Published: 2026-08-28

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K262735 for LINQ II Insertable Cardiac Monitor (ICM) (LNQ22), Substantially Equivalent on 2026-08-28. Applicant: Medtronic, Inc.. Device class: 2.

Summary

Medtronic's LINQ II Insertable Cardiac Monitor (ICM), model LNQ22, is filed under product code MXD, implantable cardiac event recorders with arrhythmia detection.

Class II, 21 CFR 870.1025. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).

Medtronic filed from Mounds View, Minnesota. FDA found it substantially equivalent 28 calendar days after receipt (July 31 to August 28, 2026).

Clearance details

Applicant: Medtronic, Inc.
Product code: Product code MXD
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2026-07-31
Decision date: 2026-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MXD

product code MXD

Injury: 1,880
Malfunction: 9,487
Total: 11,367

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.