Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System

K223630

Medtronic, Inc. · cleared 2023-04-05 · product code MXD · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The Reveal LINQ Model LNQ11 Insertable Cardiac Monitors (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. ... New to the Reveal LINQ ICM system is the AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420, included in this submission.”
AlgorithmAI ECG Classification System algorithms
source quote (p.5)
“New to the Reveal LINQ ICM system is the AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420, included in this submission. ... Performance validation testing and analysis were completed to ensure the algorithms were able to reduce false alerts from ICM detected AF and Pause episodes while retaining true alerts.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: reduce false alerts from ICM detected AF and Pause episodes while retaining true alerts

standards: ISO 14971:2019, ISO 15223-1:2016, IEC 82304-1:2017, IEC 62304:2006/ AMD 1:2015, IEC 62304:2006/AC:2008, ANSI/AAMI EC57: 2012

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/K223630