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)
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.

View all ZOLL Medical Corporation devices

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 63
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K131919.
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SIREN EPCR SUITE
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NEXXIS OR
K122167 · Barco N.V. · Apr 2013
TLINK DATA MANAGEMENT SYSTEM (DMS)
K113214 · Terumo Cardiovascular Systems Corp. · Feb 2012