MKJ — Automated External Defibrillators (Non-Wearable) Class III
Classification Details
- Product Code
- MKJ
- Device Class
- Class III
- Regulation Number
- 870.5310
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143714 | cardiac science corporation | Powerheart G5 AED | May 4, 2015 |
| K150055 | bio-detek | OneStep Pediatric CPR Multi-Function Electrode | May 2, 2015 |
| K150198 | bio-detek | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | May 2, 2015 |
| K142709 | heartsine technologies | samaritan PAD 450P | March 27, 2015 |
| K133659 | philips medical systems | HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING | January 23, 2015 |
| K133239 | zoll medical corporation, world wide headquarters | ZOLL E SERIES | January 16, 2015 |
| K142430 | physio-control | LIFEPAK 15 monitor/defibrillator | December 19, 2014 |
| K141795 | r and d batteries | BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 | December 8, 2014 |
| K142915 | zoll medical corporation | ZOLL X Series | December 3, 2014 |
| K142803 | leonhard lang | Skintact, various other tradenames | December 2, 2014 |
| K141231 | zeller power products (battery beast, llc) | ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY | November 25, 2014 |
| K141774 | zoll medical corporation | ZOLL X SERIES | November 19, 2014 |
| K133441 | bio-detek | ONESTEP CPR II MULTI-FUNCTION ELECTRODE | October 10, 2014 |
| K133484 | zoll medical | ZOLL X SERIES | August 1, 2014 |
| K133269 | zoll medical corporation, world wide headquarters | ZOLL X SERIES | May 22, 2014 |
| K131525 | defibtech | SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | April 24, 2014 |
| K122758 | cardiac science corporation | POWERHEART G5 AED | February 12, 2014 |
| K131550 | heart sync | HEART SYNC | December 6, 2013 |
| K130684 | philips medical systems | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR | October 18, 2013 |
| K131494 | heart sync | HEART SYNC | September 16, 2013 |