← Back to catalogue

Cardio Med

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103334

by Cardio Medical Products, Inc.

Identifiers

510(k) Number
K103334 FDA 510(k)
FDA Product Code
LDD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5300 FDA 510(k)
Regulation Number
870.5300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a low-energy defibrillator paddle, classified under the FDA’s Low-Energy Defibrillator category (LDD). It is designed for external cardiac defibrillation to restore normal heart rhythm during cardiac arrest by delivering controlled electrical shocks to the chest. The device is intended for use in emergency resuscitation settings where rapid intervention is critical.

The Cardio Med Defibrillator Pads are supplied as single-use, non-sterile electrodes intended for one-time application. They are regulated under FDA’s 510(k) clearance process, with a traditional review pathway and classified as a Class II medical device (regulation number 870.5300). Pads are packaged for emergency access and must be stored in a dry, temperature-controlled environment as per manufacturer guidelines. No MRI safety information is specified.

Frequently asked questions

Are these defibrillator paddles meant for repeated use, or are they single-use only?

These Cardio Med defibrillator paddles are explicitly designed for single-use only. The manufacturer specifies they are non-sterile and intended for one-time application during emergency resuscitation, ensuring safety and compliance with clinical protocols.

What storage conditions are required to maintain the integrity of these defibrillator paddles?

The manufacturer recommends storing these paddles in a dry, temperature-controlled environment to preserve their functionality. Proper storage is critical for emergency access, as the packaging is optimized for rapid deployment in resuscitation settings.

What sizes or models of these defibrillator paddles are available?

The provided data does not specify exact sizes or model variations (e.g., adult vs. pediatric), but the device is classified under FDA’s Low-Energy Defibrillator (LDD) category, which typically includes standard adult-sized paddles. For precise sizing, refer to the manufacturer’s packaging or technical documentation.

How are these defibrillator paddles regulated by the FDA, and what does that mean for clinicians?

These paddles are FDA-cleared under a 510(k) submission (K103334), following a traditional review pathway and classified as a Class II device (regulation 870.5300). This means they meet FDA standards for safety and effectiveness as a low-energy defibrillator, ensuring they can be legally used in emergency cardiac resuscitation settings as intended.

Can these paddles be used in environments where MRI scans are performed nearby?

The manufacturer does not provide MRI safety information for these paddles, meaning their compatibility with MRI environments is unspecified. Clinicians should avoid using them in proximity to MRI machines unless confirmed safe by the manufacturer or regulatory documentation.

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. Sources consulted: Cardio Medical Products | Scatter Radiation | Defibrillator Pads ..., Cardio Medical Products, Inc. - medical devices, Home - Cardio Med, Cardio Medical Products, Inc. Information - RocketReach

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cardio Medical Products, Inc.

Sources (1)

  • FDA 510(k) K103334 24 fields · synced Sep 20, 2026