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Pediatric Attenuated Defibrillation Electrodes (9730 +3 more)

FDA 510(k)

Class III (US FDA 510(k))

510(k) K022929

by Cardiac Science Corporation

Identifiers

510(k) Number
K022929 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)
Models / Variants
9730 FDA 510(k)
Powederheart Aed FDA 510(k)
Model 9200 FDA 510(k)
9210 FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.5310 FDA 510(k)
Regulation Number
870.5310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pediatric Attenuated Defibrillation Electrodes, Model 9730, are designed for use with automated external defibrillators (non-wearable) to deliver defibrillation therapy to pediatric patients. These electrodes are specifically adapted to provide appropriate energy levels for smaller pediatric chests, reducing the risk of excessive current delivery compared to adult-sized electrodes.

These electrodes are supplied as single-use, non-sterile devices intended for emergency use in out-of-hospital cardiac arrest scenarios. They are compatible with the Powderheart AED, Models 9200/9210, and are classified as Class III medical devices under FDA regulations (21 CFR 870.5310). The device received FDA 510(k) clearance through a traditional review process, with a decision code of SESE (Substantially Equivalent) by the Cardiovascular Advisory Committee.

Frequently asked questions

Are these electrodes suitable for use on adult patients, or are they specifically designed for pediatric patients only?

These electrodes, Model 9730, are specifically designed for pediatric patients only. They are adapted to deliver appropriate defibrillation energy levels for smaller pediatric chests, reducing the risk of excessive current delivery compared to adult-sized electrodes. Using them on adults could result in inadequate therapy.

What automated external defibrillators (AEDs) are these electrodes compatible with?

The Pediatric Attenuated Defibrillation Electrodes, Model 9730, are designed exclusively for use with the Powderheart AED, Models 9200 and 9210. They are not compatible with other AED models.

Are these electrodes reusable, or are they intended for single-use only?

These electrodes are intended for single-use only. They are non-sterile and designed for emergency use in out-of-hospital cardiac arrest scenarios, which aligns with the typical single-use model for defibrillation electrodes to ensure safety and hygiene.

How should these electrodes be stored, and what are the conditions for maintaining their effectiveness?

While the data does not specify exact storage conditions, the electrodes are single-use and non-sterile, so they should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. Since they are intended for emergency use, they should be kept in a readily accessible location, such as an emergency kit or defibrillator cabinet.

What is the regulatory pathway for these electrodes, and how were they cleared for use?

The Pediatric Attenuated Defibrillation Electrodes, Model 9730, received FDA 510(k) clearance through a traditional review process. The clearance was determined to be substantially equivalent (SESE) by the Cardiovascular Advisory Committee, which is part of the FDA’s review process for Class III medical devices. This means the device was compared to a legally marketed predicate device and found to have the same intended use, technological characteristics, and performance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardiac Science Corporation
FDA Applicant
Cardiac Science, Inc.

Sources (1)

  • FDA 510(k) K022929 24 fields · synced Sep 18, 2026