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LifePak 200

FDA 510(k)

Class III (US FDA 510(k))

510(k) K853564

by Physio-Control Corp.

Identifiers

510(k) Number
K853564 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 200 is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It automatically analyzes heart rhythms and advises users on whether a shock is required, making it suitable for use by trained responders and laypersons in emergency settings.

This device is supplied as a reusable medical instrument and is intended for use in both pre-hospital and in-hospital environments. It is classified as a Class III medical device under FDA regulations (870.5310) and has undergone FDA 510(k) clearance through the Traditional pathway, with a decision date of October 11, 1985. The LifePak 200 is not intended for MRI use and must be stored in accordance with manufacturer guidelines to maintain functionality and sterility.

Frequently asked questions

Is the LifePak 200 designed for use by untrained individuals, or is it primarily meant for healthcare professionals in emergency settings?

The LifePak 200 is explicitly designed for use by both trained responders and laypersons in emergency settings. It automatically analyzes heart rhythms and provides voice-guided instructions, including whether a shock is required, making it accessible to users without advanced medical training.

How is the LifePak 200 supplied, and is it intended for single-use or reusable applications?

The LifePak 200 is supplied as a reusable medical instrument, meaning it is not intended for single-use. It is designed for repeated use in both pre-hospital and in-hospital environments, provided it is maintained and stored according to manufacturer guidelines.

What storage conditions are required to maintain the functionality and sterility of the LifePak 200?

The LifePak 200 must be stored in accordance with the manufacturer’s guidelines to preserve its functionality and sterility. While the data does not specify exact storage conditions, it explicitly states that proper storage is critical to ensure the device remains operational and safe for use.

Can the LifePak 200 be used inside an MRI environment, or are there any restrictions?

The LifePak 200 is explicitly not intended for MRI use. This restriction is clearly stated in the device description, so it should not be used in proximity to MRI machines or environments where magnetic fields are present.

What regulatory pathway was followed for FDA clearance of the LifePak 200, and when was the decision made?

The LifePak 200 underwent FDA 510(k) clearance through the Traditional pathway, with a decision date of October 11, 1985. It was determined to be substantially equivalent to a predicate device, and the submission was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee.

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
Physio-Control Corp.

Sources (1)

  • FDA 510(k) K853564 24 fields · synced Sep 18, 2026