Cleared Traditional

K132960 - BIOMONITOR

K132960 is an FDA 510(k) clearance for BIOMONITOR, manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code MXD cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K132960 · Biotronik, Inc. · Cardiovascular device
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Jun 2014
Decision
259d
Days
Class 2
Risk

K132960 is an FDA 510(k) clearance for the BIOMONITOR. 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 June 6, 2014 after a review of 259 days - an extended review cycle.

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

FDA 510(k) Submission Details - K132960

510(k) Number K132960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2013
Decision Date June 06, 2014
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXD Device Classification - Class 2, Special Controls

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.