Cleared Traditional

K132488 - ZOLL CODE WRITER

K132488 is the FDA 510(k) clearance for ZOLL CODE WRITER by ZOLL Medical Corporation. It is a Class 2 Cardiovascular device (product code DXJ) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K132488 · ZOLL Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
238d
Days
Class 2
Risk

K132488 is an FDA 510(k) clearance for the ZOLL CODE WRITER. 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 April 3, 2014 after a review of 238 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

Submission Details

510(k) Number K132488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2013
Decision Date April 03, 2014
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
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 50
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K132488.
CARESCAPE Central Station V2
K162012 · Ge Healthcare · Sep 2016
Philips CS770 IntelliSpace Critical Care and Anesthesia
K151366 · Philips Medical Systems · Oct 2015
SIVR56-T KIT
K133994 · Barco N.V. · Dec 2014
NEXXIS OR
K122167 · Barco N.V. · Apr 2013
TLINK DATA MANAGEMENT SYSTEM (DMS)
K113214 · Terumo Cardiovascular Systems Corp. · Feb 2012
VANTAGE VIEW SYSTEM
K110085 · St Jude Medical · Jan 2011