Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)— 510(k) K251221

Name: FDA 510(k) clearance K251221
Creator: U.S. Food and Drug Administration
Published: 2025-09-17

Substantially Equivalent

Abbott

FDA 510(k) clearance K251221 for Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000), Substantially Equivalent on 2025-09-17. Applicant: Abbott. Device class: 2.

Clearance details

Applicant: Abbott
Product code: Code MXD
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2025-04-21
Decision date: 2025-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MXD

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K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)2026-08-28
K261074 — BIOMONITOR IV (471155)2026-05-01
K253516 — Assert-IQ (DM5100)2025-12-18
K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)2025-09-12
K240693 — LINQ II Insertable Cardiac Monitor (ICM)2024-03-28

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Adverse events under product code MXD

product code MXD

Injury: 1,880
Malfunction: 9,487
Total: 11,367

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.