Cleared Special

K131919 - ZOLL EPCR IOS

K131919 is an FDA 510(k) clearance for ZOLL EPCR IOS, manufactured by ZOLL Medical Corporation. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Special 510(k) pathway after a 174-day FDA review.

K131919 · ZOLL Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
174d
Days
Class 2
Risk

K131919 is an FDA 510(k) clearance for the ZOLL EPCR IOS. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by ZOLL Medical Corporation (Chelsmford, US). The FDA issued a Cleared decision on December 17, 2013 after a review of 174 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K131919

510(k) Number K131919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2013
Decision Date December 17, 2013
Days to Decision 174 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Modification to existing cleared device.

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 78
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K131919.
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K131272 · Medusa Medical Technologies, Inc. · Jan 2014
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K131816 · Sorin Group Deutschland GmbH · Jul 2013
NEXXIS OR
K122167 · Barco N.V. · Apr 2013
TLINK DATA MANAGEMENT SYSTEM (DMS)
K113214 · Terumo Cardiovascular Systems Corp. · Feb 2012
K131919 · ZOLL EPCR IOS
Download PDF FDA Summary ZOLL Medical Corporat…