Cleared Traditional

MODEL #100 SHOCK-TRODE CHILD DEFIB PADS (K911455) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911455 · Cardiotronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
196d
Days
Class 2
Risk

K911455 is an FDA 510(k) clearance for the MODEL #100 SHOCK-TRODE CHILD DEFIB PADS. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Cardiotronics, Inc. (West Carlsbad, US). The FDA issued a Cleared decision on October 16, 1991 after a review of 196 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 Cardiotronics, Inc. devices

Submission Details

510(k) Number K911455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1991
Decision Date October 16, 1991
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
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 165
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K911455.
Switched Internal Paddles
K203231 · Philips North America, LLC · Jan 2021
Tempus LS - Manual
K200849 · Remote Diagnostic Technologies, Ltd. A Philips Company · Jul 2020
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
K182503 · Physio-Control, Inc. · Jun 2019
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
K910754 · Hewlett-Packard Co. · May 1991
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403 · Hewlett-Packard Co. · Aug 1989
MODEL 43130A DEFIBRILLATOR
K853439 · Hewlett-Packard Co. · Oct 1985