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510(k) K261074

BIOMONITOR IV (471155) by Biotronik, Inc. — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2026
Date Received
April 1, 2026
Clearance Type
Special
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

Other clearances by Biotronik, Inc.

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  • K222065 — Passeo-35 Xeo Peripheral Dilatation Catheter (February 16, 2023)
  • K221856 — BIOMONITOR IIIm, BIOMONITOR III (July 27, 2022)
  • K222037 — Selectra Lead Implantation System (July 19, 2022)
  • K214038 — Oscar Peripheral Multifunctional Catheter system (July 6, 2022)
  • K201445 — MultiCath, AcQRate Dx Fixed Curve Catheter (September 2, 2021)

Other clearances for product code MXD

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  • K251221 — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (September 17, 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)