Cleared Traditional

K131272 - SIREN EPCR SUITE (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 77
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K131272.
ESSENZ Patient Monitor
K212003 · Livanova Deutschland, GmbH · Nov 2021
Philips IntelliVue GuardianSoftware (Rev. E.0X)
K212208 · Philips Medizin Systeme Boeblingen GmbH · Sep 2021
Essence 55SP Large Monitor System
K201162 · Shenyang Torch-Bigtide Digital Technology Co., Ltd. · Aug 2020
Philips IntelliVue GuardianSoftware
K180534 · Philips Medizin Systeme Boeblingen GmbH · Jul 2018
Nexxis OR
K173381 · Barco N.V. · Feb 2018