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LifePak 20E

FDA 510(k)

Class III (US FDA 510(k))

510(k) K073089

by PHYSIO-CONTROL, Inc.

Identifiers

510(k) Number
K073089 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 LifePak 20E is an Automated External Defibrillator (Non-Wearable), designed to deliver defibrillation therapy and monitor cardiac rhythms in emergency settings. It combines manual defibrillation capabilities with automated external defibrillator (AED) functionality, ECG monitoring, and noninvasive pacing for comprehensive cardiac support.

Supplied as a reusable device, the LifePak 20E is intended for use in hospital environments, including patient transport and crash cart applications. It is not classified as single-use and requires proper maintenance and calibration. The device holds an FDA 510(k) clearance under the classification of Class III medical devices, adhering to regulatory standards for cardiovascular applications.

Frequently asked questions

Is the LifePak 20E designed for use outside of hospital settings like public places or ambulances, or is it strictly for in-hospital use?

The LifePak 20E is explicitly designed for hospital environments, including patient transport and crash cart applications. While it offers comprehensive cardiac support like defibrillation, ECG monitoring, and noninvasive pacing, its reusable nature and maintenance requirements align with controlled clinical settings rather than public or pre-hospital use.

How is the LifePak 20E different from a standard automated external defibrillator (AED) in terms of functionality?

Unlike standard AEDs, the LifePak 20E combines automated defibrillation with manual defibrillation capabilities, ECG monitoring, and noninvasive pacing. This dual functionality makes it suitable for advanced cardiac support in hospital settings, where clinicians may need to intervene beyond automated guidance.

What kind of maintenance does the LifePak 20E require, and how often should it be serviced?

Since the LifePak 20E is a reusable device, it requires proper maintenance and calibration to ensure accuracy and reliability. Physio-Control provides guidelines for servicing intervals, but exact schedules depend on usage frequency and compliance with manufacturer protocols. Regular checks are critical for defibrillators to maintain performance standards.

What regulatory pathway was followed for the FDA clearance of the LifePak 20E, and what does that mean for its classification?

The LifePak 20E received FDA 510(k) clearance under the Class III medical device classification, which applies to cardiovascular devices. This pathway confirms it meets stringent regulatory standards for safety and effectiveness, though Class III indicates higher-risk devices requiring rigorous oversight. The clearance was granted as substantially equivalent to a predicate device.

Can the LifePak 20E be used for patient transport within a hospital, or is it only for stationary use?

Yes, the LifePak 20E is explicitly designed for patient transport within hospital settings, in addition to stationary use in crash carts. Its robust construction and advanced cardiac monitoring capabilities make it suitable for mobile applications where continuous cardiac support is needed during transfers.

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: Physio-control LIFEPAK 20e manuals, PDF LIFEPAK 20 e DEFIBRILLATOR/MONITOR - sakomed.com, Complete Physio-Control LIFEPAK 20e Defibrillator Monitor, PDF Physio-Control LIFEPAK 20e

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
PHYSIO-CONTROL, Inc.

Sources (1)

  • FDA 510(k) K073089 24 fields · synced Sep 18, 2026