Cardiovascular · PMA · 2022
Avive Automated External Defibrillator (AED) System
Avive Solutions, Inc.. Approved by FDA on 31 October 2022 under submission P210015, product code MKJ (automated external defibrillators (non-wearable)). What FDA's record says, in FDA's words.
Device record · P210015
- Device. Avive Automated External Defibrillator (AED) SystemDEVICE
- Company. Avive Solutions, Inc.COMPANY
- Decision. 31 October 2022, PMA, apprDECISION
- Panel. CardiovascularPANEL
- Product code. MKJ, Automated External Defibrillators (Non-Wearable)CODE
- Regulation. 21 CFR 870.5310, Class IIIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement, verbatim, from the decision document.
The Avive Automated External Defibrillator (AED) is intended for emergency treatment of individuals who are exhibiting symptoms of cardiac arrest. A person in cardiac arrest: x Is unresponsive; and x Is not breathing normally. The Avive AED analyzes the patient’s electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock to treat ventricular fibrillation or pulseless ventricular tachycardia. The Avive AED is indicated for adult and pediatric patients over 1 years of age. When a patient is less than 8 years old, or weighs less than 55 lbs., the Avive AED should be used in Child Mode. Otherwise, the Avive AED should be used in Adult Mode. Therapy should not be delayed in order to determine exact age and/or weight.
The product code's definition, from FDA's classification record. This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 270,712 reports filed against devices carrying product code MKJ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · HeartSine samaritan PAD 360P · HeartSine Technologies LTD · report 3004123209-2026-00450
30 September 2026 · Malfunction · HeartStart MRx -EMS Defibrillator · Philips North America LLC · report 3030677-2026-101048
This report is based on information provided by Philips authorized service provider (ASP) with an investigation documented by Philips Complaint Handling. Philips received a complaint on the HeartStart MRx ALS monitor indicating that the device does not pass the functional test due to that it had defibrillation problems and did not detect the load cable.
30 September 2026 · Malfunction · HeartStart XL+ Defibrillator/Monitor · Philips North America LLC · report 3030677-2026-101047
Philips received a complaint on the Defibrillator indicating that after the device displays a cross and beep every 30 seconds. After the manual test, defibrillation test failed. There was no patient involvement.
30 September 2026 · Malfunction · HeartStart MRx monitor/defib · Philips North America LLC · report 3030677-2026-101049
This report is based on information provided by Philips authorized service provider (ASP) with an investigation documented by Philips Complaint Handling. Philips received a complaint on the HeartStart MRx monitor/defib indicating that the functional test failed. There was no patient involvement.
30 September 2026 · Malfunction · HeartStart XL+ Defibrillator/Monitor · Philips North America LLC · report 3030677-2026-101051
Philips received a complaint on the Defibrillator indicating that the self check failed. There was no patient involvement.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MKJ, in Cardiovascular, or approved in 2022. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.