Cleared Traditional

K931804 - ZOLL D 5400 ADULT SOLID GEL DEFIBRILLAT...

K931804 is the FDA 510(k) clearance for ZOLL D 5400 ADULT SOLID GEL DEFIBRILLAT... by Zoll Medical Corp. It is a Class 2 Cardiovascular device (product code LDD) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K931804 · Zoll Medical Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
179d
Days
Class 2
Risk

K931804 is an FDA 510(k) clearance for the ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Zoll Medical Corp (Burlington, US). The FDA issued a Cleared decision on October 8, 1993 after a review of 179 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - 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 Corp devices

Submission Details

510(k) Number K931804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1993
Decision Date October 08, 1993
Days to Decision 179 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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 - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 51
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K931804.
CARDIOSERV S
K962551 · Marquette Electronics, Inc. · Nov 1996
VITAL-COMBO(R)
K922315 · Physio-Control Corp. · Mar 1994
LIFEPAK 9 DEFIBRILLATOR/MONITOR
K935674 · Physio-Control Corp. · Dec 1993
LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER
K931053 · Physio-Control Corp. · May 1993
MARQUETTE SERIES 360 DEFIBRILLATOR
K921487 · Marquette Electronics, Inc. · Dec 1992
PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG
K912966 · Physio-Control Corp. · Feb 1992