Cleared Traditional

K131272 - SIREN EPCR SUITE

K131272 is an FDA 510(k) clearance for SIREN EPCR SUITE, manufactured by Medusa Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K131272 · Medusa Medical Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
245d
Days
Class 2
Risk

K131272 is an FDA 510(k) clearance for the SIREN EPCR SUITE. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Medusa Medical Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on January 3, 2014 after a review of 245 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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 Medusa Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K131272

510(k) Number K131272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2013
Decision Date January 03, 2014
Days to Decision 245 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
120d slower than avg
Panel avg: 125d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXJ Device Classification - Class 2, Special Controls

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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 - DXJ Display, Cathode-ray Tube, Medical

All 61
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K131272.
SIVR56-T KIT
K133994 · Barco N.V. · Dec 2014
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
K133882 · Ge Medical Systems Information Technologies, Inc. · Apr 2014
ZOLL CODE WRITER
K132488 · ZOLL Medical Corporation · Apr 2014
ZOLL EPCR IOS
K131919 · ZOLL Medical Corporation · Dec 2013
SORIN CONNECT DATA MANAGEMENT SYSTEM
K131816 · Sorin Group Deutschland GmbH · Jul 2013
NEXXIS OR
K122167 · Barco N.V. · Apr 2013