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The Tracker / August 2026 / K262735

510(k) cleared

LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)

Medtronic, Inc. · Aug 28, 2026 · K262735

FDA cleared the LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) from Medtronic, Inc. on Aug 28, 2026 under K262735, a special 510(k). The device falls under product code MXD, Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection), regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 31, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Medtronic, Inc. has 8 other decisions in the tracker over the last 12 months: K262005 (Affera Integrated Mapping System), K261335 (VitalFlow Set with Balance Biosurface), K261866 (Concerto Versa Detachable Coil), K253530 (Trexon Monofilament Synthetic Absorbable Suture).

Questions & Answers

What did FDA clear under K262735?

K262735 is the FDA 510(k) for LINQ II Insertable Cardiac Monitor (ICM) (LNQ22), submitted by Medtronic, Inc.. FDA's decision date was Aug 28, 2026, under product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)).

Who makes the LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)?

Medtronic, Inc., based in Mounds View, MN, is the applicant of record for K262735.

How long did the K262735 review take?

FDA received the submission on Jul 31, 2026 and issued its decision on Aug 28, 2026, 28 days later.

← All decisions in August 2026