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510(k) K251221

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) by Abbott — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2025
Date Received
April 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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Other clearances for product code MXD

  • K253516 — Assert-IQ (DM5100) (December 18, 2025)
  • K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monit (September 12, 2025)
  • K240693 — LINQ II™ Insertable Cardiac Monitor (ICM) (March 28, 2024)
  • K233562 — LINQ II Insertable Cardiac Monitor (December 6, 2023)
  • K233320 — LINQ II™ Insertable Cardiac Monitor (LNQ22) (October 31, 2023)
  • K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312) (August 19, 2023)
  • K230375 — BIOMONITOR IV (May 19, 2023)
  • K230553 — LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application (April 26, 2023)
  • K223630 — Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, Accu (April 5, 2023)
  • K221962 — LINQ II Insertable Cardiac Monitor (August 25, 2022)