Cleared Traditional

K911456 - MODEL #110 STEALTH-TRODE CHILD DEFIB PADS

K911456 is an FDA 510(k) clearance for MODEL #110 STEALTH-TRODE CHILD DEFIB PADS, manufactured by Cardiotronics, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K911456 · Cardiotronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
196d
Days
Class 2
Risk

K911456 is an FDA 510(k) clearance for the MODEL #110 STEALTH-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

FDA 510(k) Submission Details - K911456

510(k) Number K911456 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
Combination Product No
PCCP Authorized No
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.

LDD Device Classification - Class 2, Special Controls

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 81
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K911456.
ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION
K914458 · Medical Data Electronics · Dec 1991
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
K914971 · Nihon Kohden America, Inc. · Dec 1991
MODEL #100 SHOCK-TRODE CHILD DEFIB PADS
K911455 · Cardiotronics, Inc. · Oct 1991
MODEL #911 STEALTH MULTI PADS
K912621 · Cardiotronics, Inc. · Oct 1991
MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS
K911662 · Marquette Electronics, Inc. · Oct 1991
MODEL #350 SHOCK-PLATE DEFIB ADAPTOR
K911402 · Cardiotronics, Inc. · Oct 1991