LINQ II Insertable Cardiac Monitor

K233562

Medtronic, Inc. · cleared 2023-12-06 · product code MXD · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The LINQ II ICM is an insertable automatically-activated and patient activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, 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 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.”
Algorithmcontinuously sense the patient's subcutaneous ECG, and analyze the timing of ventricular events to detect possible episodes of arrhythmia.
source quote (p.6)
“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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“The following standards were used for development and testing of the CareLink SmartSync LINQ II Platform Application. ... 82304-1:2017 IEC 13-97 Health software Part 1: General requirements for product safety ... 62304:2006/ AMD 1:2015 IEC 13-79 Medical device software - Software life cycle processes”

Validation studies (1)

Bench

sample size not stated

endpoints: met design requirements and established performance criteria; met the functionality per the requirements; all test executions resulted in a status of Passed; met design input requirements under actual or simulated use conditions; All results met the criteria in the Validation Plan

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
0
drift signals on this device

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/K233562