LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application

K230553

Medtronic, Inc. · cleared 2023-04-26 · product code MXD · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient Assistant to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event. LINQ II ICM includes the following accessories: LINQ II Tool Kit Model LNQ22TK, Reveal LINQ™™ Mobile Manager Model MSW002, Device Command Library Model 2692, Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, and ZA420. New to the LINQ II ICM system is the CareLink SmartSync LINQ II ICM Application Model D00U024.”
AlgorithmThe device is designed to automatically record the occurrence of an arrhythmia in a patient, continuously sense the patient's subcutaneous ECG, and analyze the timing of ventricular events to detect possible episodes of arrhythmia. It includes the AccuRhythm AI ECG Classification System.
source quote (p.5)
“The LINQ II ICM will continue to use the same technology. It is designed to automatically record the occurrence of an arrhythmia in a patient, continuously sense the patient's subcutaneous ECG, and analyze the timing of ventricular events to detect possible episodes of arrhythmia. The LINQ II ICM has a small form factor, and uses Sapphire, Titanium, Parylene, and Titanium Nitride coating on the sensing electrodes as body contacting materials. LINQ II ICM includes the following accessories: LINQ II Tool Kit Model LNQ22TK, Reveal LINQ™™ Mobile Manager Model MSW002, Device Command Library Model 2692, Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, and ZA420.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

standards: ISO 14971:2019, ISO 15223-1:2016, IEC 82304-1:2017, IEC 62304:2006/AMD 1:2015, IEC 62304:2006/AC:2008

Standalone

sample size not stated

standards: ISO 14971:2019, ISO 15223-1:2016, IEC 82304-1:2017, IEC 62304:2006/AMD 1:2015, IEC 62304:2006/AC:2008

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

3
recalls in product code, 24mo
3444
MAUDE reports in code, 12mo
+49%
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233562 (decision 2023-12-06) from Medtronic, Inc. for a matching device line ("LINQ II Insertable Cardiac Monitor") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233562

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Medtronic Inc.) — same firm and product code, not necessarily this device · initiated 2023-11-03

    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 occasional noise due to device position/migration, patient activity, or external electromagnetic interference.

    recall event 93411 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K230553