Is your AED approved by the FDA?
What the FDA wants you to know:
To help ensure the quality and reliability of automated external defibrillators (AEDs), the FDA has established more stringent regulatory requirements. The FDA published a final order in February 2015 requiring premarket approval (PMA) applications for new and existing AEDs and AED accessories. If your AED is not FDA-approved, the accessories necessary for your AED may no longer be supported by the manufacturer, and thus will no longer be available after February 3, 2021.
What this means to you:
To ensure the availability of lifesaving treatment with the AEDs in your facilities, we encourage you to determine whether your AED is FDA-approved, and if it is not, to begin making plans to transition to an FDA-approved AED. If your AED is not FDA-approved, the accessories necessary for your AED may no longer be supported by the manufacturer and will not be available after February 3, 2021.
If the manufacturer HAS FILED for PMA (or has already received approval), those AEDs and related accessories will continue to be available. You do not need to replace them.
The FDA recommends that you take the following steps:
• Determine the brand and model of your AED. Most AEDs indicate the brand and model on the back of the device. In some cases it is also printed on the front.
• To see if your AED is FDA-approved, check the list on this document or on FDA.gov.
• If your AED is not listed, plan to transition to an FDA-approved AED by February 3, 2021.
• Given the importance of these devices in emergency situations, the FDA recommends that you continue to keep your AED available for use until you obtain an FDA-approved AED.
For Philips HeartStart FR2 AED Users:
HeartStart FR2/FR2+ and associated accessories, with the exception of pads and batteries, have reached or will reach end-of-life/end-of-shipment dates in the United States before February 3, 2021. In the United States, orders for FR2/FR2+ pads and batteries can be placed until December 31, 2020 and orders will be fulfilled, as inventory allows, through February 3, 2021.
For Physio Control LIFEPAK Users:
Stryker has announced the end of support for the LIFEPAK 12 monitor/defibrillator, LIFEPAK 20 defibrillator/monitor, LIKEPAK 500 AED, and Heartsine samaritan PAD 300 and 300P.
FDA-Approved Automated External Defibrillators (AEDs)
|Manufacturer||Device Name and Model Number|
|Cardiac Science||Powerheart G3 (model 9300)
Powerheart G3 Plus (model 9390)
Powerheart G5 (all models)
Powerheart G3 Pro
Lifeline/Reviver View (DDU-2200/DDU-2300)
Lifeline/Reviver ECG (DDU-2450/DDU-2475)
|Heartsine (Stryker)||Samaritan SAM 350P
Samaritan SAM 360P
Samaritan SAM 450P
|Philips Medical||HeartStart Home
|LifePak CR Plus (all models)
LifePak CR 2 (all models)
LifePak 1000 (all models)
|ZOLL Medical||AED Plus (all models)
AED Pro (all models)
ZOLL AED BLS
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