Cleared Traditional

K230375 - BIOMONITOR IV

K230375 is the FDA 510(k) clearance for BIOMONITOR IV by Biotronik, Inc.. It is a Class 2 Cardiovascular device (product code MXD) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K230375 · Biotronik, Inc. · Cardiovascular device
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May 2023
Decision
95d
Days
Class 2
Risk

K230375 is an FDA 510(k) clearance for the BIOMONITOR IV. Classified as Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (product code MXD), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on May 19, 2023 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K230375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2023
Decision Date May 19, 2023
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

All 32
Devices cleared under the same product code (MXD) and FDA review panel - the closest regulatory comparables to K230375.
LINQ II Insertable Cardiac Monitor
K233562 · Medtronic, Inc. · Dec 2023
LINQ II™ Insertable Cardiac Monitor (LNQ22)
K233320 · Medtronic, Inc. · Oct 2023
LUX-Dx II (M302)
K231328 · Boston Scientific Corp · Aug 2023
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
K230553 · Medtronic, Inc. · Apr 2023
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
K223630 · Medtronic, Inc. · Apr 2023
LINQ II Insertable Cardiac Monitor
K221962 · Medtronic, Inc. · Aug 2022