Assert-IQ (DM5100)

K253516

Abbott Medical · cleared 2025-12-18 · product code MXD · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.1)
“Trade/Device Name: Assert-IQTM Insertable Cardiac Monitor System Powered by Al”
AlgorithmAutomated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals. Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with physician programmable values for AF duration. The ability to inhibit EGM storage due to noise and allow for detection and storage of AF and non-AF (pause, bradycardia, and tachycardia) arrhythmias after noise exit.
source quote (p.6)
“Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals, which is identical in Assert-IQ™™ ICM models DM5500 and DM5000. Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with physician programmable values for AF duration. The ability to inhibit EGM storage due to noise and allow for detection and storage of AF and non-AF (pause, bradycardia, and tachycardia) arrhythmias after noise exit, which is identical Assert-IQ™™ ICM models DM5500 and DM5000.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“Cybersecurity: No changes to cybersecurity profile, controls, or risk assessments. No new vulnerabilities identified since last clearance (Sept 17, 2025). Cybersecurity Maintenance Plan and Software Bill of Materials (SBOM) are up to date and compliant with FDA Section 524B(b)(1) and 524B(b)(3).”

Validation studies (7)

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standards: ISO 11135

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

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/K253516