Avive Automated External Defibrillator (AED) System is an AI-enabled medical device from Avive Solutions, Inc. that the U.S. FDA approved through PMA P210015 on October 31, 2022. Its lead review panel is Cardiovascular and its primary product code is MKJ.
See also FDA-cleared AI cardiovascular devices in 2022, all FDA AI clearances in 2022, top cardiovascular AI devices.
Key facts
| Submission number | P210015 |
|---|---|
| Pathway | PMA |
| Date of final decision | |
| Company (FDA list) | Avive Solutions, Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | MKJ |
Source: FDA AI-Enabled Medical Devices list. No matching openFDA record was found for this submission yet.
What this means
Premarket Approval (PMA) is FDA's most stringent pathway, used for Class III devices. It requires valid scientific evidence of safety and effectiveness. Avive Automated External Defibrillator (AED) System went through this pathway (P210015).
Product code MKJ covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Avive Solutions, Inc. has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.