Cleared Special

K142182 - FRIMAP ADAPTER CONNECTOR (MAC)

K142182 is an FDA 510(k) clearance for FRIMAP ADAPTER CONNECTOR (MAC), manufactured by Topera, Inc.. The device is a Class 2 Cardiovascular device with product code MTD cleared through the Special 510(k) pathway after a 32-day FDA review.

K142182 · Topera, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Sep 2014
Decision
32d
Days
Class 2
Risk

K142182 is an FDA 510(k) clearance for the FRIMAP ADAPTER CONNECTOR (MAC). Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Topera, Inc. (St.Louis, US). The FDA issued a Cleared decision on September 9, 2014 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Topera, Inc. devices

FDA 510(k) Submission Details - K142182

510(k) Number K142182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2014
Decision Date September 09, 2014
Days to Decision 32 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

MTD Device Classification - Class 2, Special Controls

Product Code MTD Catheter, Intracardiac Mapping, High-density Array
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 - MTD Catheter, Intracardiac Mapping, High-density Array

All 26
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