Cleared Traditional

K132488 - ZOLL CODE WRITER

K132488 is an FDA 510(k) clearance for ZOLL CODE WRITER, 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 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

FDA 510(k) Submission Details - K132488

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
Combination Product No
PCCP Authorized No
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.

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 K132488.
Philips IntelliVue GuardianSoftware
K151736 · Philips Medizin Systeme Boblingen GmbH · Oct 2015
SIVR56-T KIT
K133994 · Barco N.V. · Dec 2014
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
K133882 · Ge Medical Systems Information Technologies, Inc. · Apr 2014
SIREN EPCR SUITE
K131272 · Medusa Medical Technologies, Inc. · Jan 2014
ZOLL EPCR IOS
K131919 · ZOLL Medical Corporation · Dec 2013
SORIN CONNECT DATA MANAGEMENT SYSTEM
K131816 · Sorin Group Deutschland GmbH · Jul 2013