Cleared Traditional

K153739 - MRI Patient Monitor TeslaDUO

K153739 is an FDA 510(k) clearance for MRI Patient Monitor TeslaDUO, 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 183-day FDA review.

K153739 · 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
Jun 2016
Decision
183d
Days
Class 2
Risk

K153739 is an FDA 510(k) clearance for the MRI Patient Monitor TeslaDUO. 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 (Mammendorf, DE). The FDA issued a Cleared decision on June 28, 2016 after a review of 183 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 - K153739

510(k) Number K153739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2015
Decision Date June 28, 2016
Days to Decision 183 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
58d slower than avg
Panel avg: 125d · This submission: 183d
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 Consultant

Emergo Group
ANDRE KINDSVATER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

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