MKJ · Automated External Defibrillators (Non-Wearable)
Cardiovascular · 21 CFR 870.5310 · Class 3
Overview
| Product Code | MKJ |
|---|---|
| Device Name | Automated External Defibrillators (Non-Wearable) |
| Regulation | 21 CFR 870.5310 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
Identification
An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.
Classification Rationale
Class III (premarket approval)
Recent Cleared Devices (20 of 245)
Showing 20 most recent of 245 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P200005 | TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors | Tz Medical, Inc. | Jan 9, 2024 | APPR |
| P200007 | HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads | Graphic Controls D.B.A. Vermed | Jun 23, 2023 | APPR |
| P210015 | Avive Automated External Defibrillator (AED) System | Avive Solutions, Inc. | Oct 31, 2022 | APPR |
| P200004 | ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters | Conmed Corporation | Sep 26, 2021 | APPR |
| P190013 | AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) | Aed Battery Exchange, LLC | Feb 2, 2021 | APPR |
| P190007 | Cardinal Health Multifunctional Defibrillation Electrode | Cardinalhealth | Aug 7, 2020 | APPR |
| P180028 | HeartStart FRx Defibrillator | Philips Medical Systems | May 11, 2020 | APPR |
| P160028 | Philips HeartStart FR3 Defibrillator | Philips Medical Systems, Inc. | May 11, 2020 | APPR |
| P170018 | LIFEPAK® CR2 Defibrillator | Physio-Control, Inc. | Dec 21, 2018 | APPR |
| P160033 | Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3 | ZOLL Medical Corporation | Dec 7, 2018 | APPR |
| P160034 | Powerheart® AED G3 Pro | ZOLL Medical Corporation | Dec 6, 2018 | APPR |
| P160026 | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE | Physio-Control, Inc. | Jul 2, 2018 | APPR |
| P160032 | Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- | Defibtech, LLC | Feb 1, 2018 | APPR |
| P160022 | X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower | ZOLL Medical Corporation | Dec 27, 2017 | APPR |
| P160012 | LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger | Physio-Control, Inc. | Dec 21, 2017 | APPR |
| P160015 | AED Plus and Fully Automatic AED Plus | ZOLL Medical Corporation | May 26, 2017 | APPR |
| P160008 | HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) | Heartsine Technologies, Ltd. | Jan 12, 2017 | APPR |
| K143714 | Powerheart G5 AED | Cardiac Science Corporation | May 4, 2015 | SESE |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | Bio-Detek, Inc. | May 2, 2015 | SESE |
| K150055 | OneStep Pediatric CPR Multi-Function Electrode | Bio-Detek, Inc. | May 2, 2015 | SESE |
Top Applicants
- ZOLL Medical Corporation — 20 clearances
- Zoll Medical Corp — 19 clearances
- Philips Medical Systems — 17 clearances
- Zoll Medical Corporation, World Wide Headquarters — 17 clearances
- Physio-Control Corp. — 11 clearances
