Reveal LINQ

K162855

Medtronic, Inc. · cleared 2017-02-23 · product code MXD · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.5)
“The Reveal LINQ ICM Model LNQ11 is a small, leadless device that is typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.”
Algorithmatrial and ventricular arrhythmia detection algorithms by adding three rules to reduce false positive detections listed below: Atrial Algorithms – Adaptive P-sense rule Dual Sense Brady rejection rule Dual Sense Asystole rejection rule
source quote (p.6)
“The Reveal LINQ ICM with modified firmware includes minor changes to enhance its atrial and ventricular arrhythmia detection algorithms by adding three rules to reduce false positive detections listed below: Atrial Algorithms – Adaptive P-sense rule Dual Sense Brady rejection rule Dual Sense Asystole rejection rule”
Adaptive (vs locked)Yes
source quote (p.6)
“Atrial Algorithms – Adaptive P-sense rule”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: met established performance criteria

standards: ANSI/AAMI EC57:1998, ISO 14971:2012, IEC EN 62304:2006, Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

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) K223630 (decision 2023-04-05) from Medtronic, Inc. for a matching device line ("Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K223630

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/K162855