MKJ — Automated External Defibrillators (Non-Wearable) Class III
FDA product code MKJ covers "Automated External Defibrillators (Non-Wearable)", a Class III medical device regulated under 21 CFR 870.5310. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K150198 | bio-detek | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | May 2, 2015 |
| K150055 | bio-detek | OneStep Pediatric CPR Multi-Function Electrode | 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 |