← Back to catalogue

Philips Heartstart Xl+, Philips Heartstart External Paddles, Philips Multifunct…

FDA 510(k)

Class III (US FDA 510(k))

510(k) K110825

by Philips Medical Systems

Identifiers

510(k) Number
K110825 FDA 510(k)
FDA Product Code
MKJ 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 HeartStart XL+ External Defibrillator Paddles and Multifunction Electrodes are automated external defibrillators (non-wearable) designed for emergency cardiac resuscitation. These devices deliver synchronized electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest by analyzing heart rhythm and advising appropriate intervention.

Supplied as single-use, non-reusable components, these electrodes are intended for use in pre-hospital and in-hospital settings by trained personnel. They are classified as Class III medical devices under FDA regulations (870.5310) and have received FDA 510(k) clearance (K110825) as substantially equivalent to predicate devices. Storage and handling follow standard sterile medical device protocols, with specific attention to expiration dates marked on packaging.

Frequently asked questions

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

These electrodes are explicitly designed for single-use only and are not intended to be reused. The manufacturer emphasizes this in the description, ensuring compliance with sterile medical device protocols to maintain patient safety.

What settings or environments are these electrodes approved for, and who can use them?

The electrodes are approved for use in both pre-hospital and in-hospital settings by trained personnel. They are not wearable devices but are intended for emergency cardiac resuscitation in situations where immediate defibrillation is required.

How should these electrodes be stored, and what should I check before use?

These electrodes follow standard sterile medical device storage protocols, meaning they should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Always verify the expiration date printed on the packaging before use to ensure sterility and functionality.

What regulatory pathway was followed for FDA clearance, and what does that mean for my facility?

The device received FDA 510(k) clearance (K110825) under the traditional review pathway, meaning it was determined to be substantially equivalent to a predicate device already on the market. This clearance falls under Class III medical devices (870.5310), which are subject to stricter regulatory oversight due to their high-risk nature. Your facility must ensure compliance with FDA guidelines for proper use and storage.

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: Global home | Philips

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
Philips Medical Systems

Sources (1)

  • FDA 510(k) K110825 24 fields · synced Sep 18, 2026