LINQ II Insertable Cardiac Monitor

K221962

Medtronic, Inc. · cleared 2022-08-25 · product code MXD · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“LINQ II ICM includes the following medical accessories: LINQ Tool Kit Model LNQ22TK, Patient Assistant Model PA97000, Reveal LINQ™ Mobile Manager Model MSW002 with patient connector Model 24967, Device Command Library Model 2692, Instrument Command Library Model 2691, and the Zelda (AccuRhythm) AI ECG Classification System Models ZA400, ZA410, and ZA420.”
AlgorithmAI ECG Classification System
source quote (p.5)
“Zelda (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

endpoints: ensure that the product operated as expected

Retrospective clinical

sample size not stated

endpoints: assess the safety and effectiveness of the LINQ II ICM existing indications for use in the pediatric patient population

standards: ISO 14971:2019, ISO 20417:2021, ISO 10993-1:2020, ISO 10993-7:2008/AC:2009, ISO 11135:2014 +A1:2019, EN 45502-1:2015

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
3
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K230553 (decision 2023-04-26) from Medtronic, Inc. for a matching device line ("LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K230553

  • 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/K221962