Cleared Traditional

K103473 - ZOLL RESCUENET EPCR MODEL RESCUENET EPCR

K103473 is an FDA 510(k) clearance for ZOLL RESCUENET EPCR MODEL RESCUENET EPCR, manufactured by ZOLL Medical Corporation. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K103473 · ZOLL Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
170d
Days
Class 2
Risk

K103473 is an FDA 510(k) clearance for the ZOLL RESCUENET EPCR MODEL RESCUENET EPCR. 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 May 13, 2011 after a review of 170 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 ZOLL Medical Corporation devices

FDA 510(k) Submission Details - K103473

510(k) Number K103473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2010
Decision Date May 13, 2011
Days to Decision 170 days
Submission Type Traditional
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
45d slower than avg
Panel avg: 125d · This submission: 170d
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 K103473.
TLINK DATA MANAGEMENT SYSTEM (DMS)
K113214 · Terumo Cardiovascular Systems Corp. · Feb 2012
INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216
K111905 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Oct 2011
RADIFORCE LARGE MONITOR SYSTEM
K112645 · Eizo GmbH · Sep 2011
VANTAGE VIEW SYSTEM
K110085 · St Jude Medical · Jan 2011
INTELLIVUE CLINICAL INFORMATION PORTFOLIO
K100272 · Philips Medical Systems · Apr 2010
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K053356 · Ge Medical Systems Information Technologies · Apr 2006