Cleared Traditional

K142032 - MRI PATIENT MONITORING SYSTEM TESLA M3

K142032 is an FDA 510(k) clearance for MRI PATIENT MONITORING SYSTEM TESLA M3, manufactured by Mipm Mammendorfer Institut Fur Physik Und Medizin. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K142032 · Mipm Mammendorfer Institut Fur Physik Und Medizin · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
286d
Days
Class 2
Risk

K142032 is an FDA 510(k) clearance for the MRI PATIENT MONITORING SYSTEM TESLA M3. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Mipm Mammendorfer Institut Fur Physik Und Medizin (The Hague, NL). The FDA issued a Cleared decision on May 7, 2015 after a review of 286 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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.

FDA 510(k) Submission Details - K142032

510(k) Number K142032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2014
Decision Date May 07, 2015
Days to Decision 286 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
161d slower than avg
Panel avg: 125d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K142032.
Sickbay Clinical Platform
K143304 · Medical Informatics Corp · May 2015
Datalys Multi-Parameter Patient Monitor
K150691 · Lutech Industries, Inc. · May 2015
740 SELECT
K150620 · Cas Medical Systems, Inc. · May 2015
COVA MONITORING SYSTEM
K142087 · Tosense, Inc. · May 2015
ViSi Mobile Monitoring System
K150361 · Sotera Wireless, Inc. · Apr 2015
AWARE
K143372 · Ambient Clinical Analytics · Apr 2015