Cleared Traditional

K133994 - SIVR56-T KIT

K133994 is an FDA 510(k) clearance for SIVR56-T KIT, manufactured by Barco N.V.. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K133994 · Barco N.V. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
340d
Days
Class 2
Risk

K133994 is an FDA 510(k) clearance for the SIVR56-T KIT. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on December 1, 2014 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Barco N.V. devices

FDA 510(k) Submission Details - K133994

510(k) Number K133994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2013
Decision Date December 01, 2014
Days to Decision 340 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 125d · This submission: 340d
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 63
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K133994.
CARESCAPE Central Station V2
K162012 · Ge Healthcare · Sep 2016
Philips CS770 IntelliSpace Critical Care and Anesthesia
K151366 · Philips Medical Systems · Oct 2015
Philips IntelliVue GuardianSoftware
K151736 · Philips Medizin Systeme Boblingen GmbH · Oct 2015
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
SIREN EPCR SUITE
K131272 · Medusa Medical Technologies, Inc. · Jan 2014