Cleared Traditional

K151139 - EasyMap MAP Catheter

K151139 is an FDA 510(k) clearance for EasyMap MAP Catheter, manufactured by Medfact Engineering GmbH. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 538-day FDA review.

K151139 · Medfact Engineering GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
538d
Days
Class 2
Risk

K151139 is an FDA 510(k) clearance for the EasyMap MAP Catheter. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Medfact Engineering GmbH (Loerrach, Baden-Wurttemberg, DE). The FDA issued a Cleared decision on October 18, 2016 after a review of 538 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Medfact Engineering GmbH devices

FDA 510(k) Submission Details - K151139

510(k) Number K151139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2015
Decision Date October 18, 2016
Days to Decision 538 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
413d slower than avg
Panel avg: 125d · This submission: 538d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 99
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