LDD · Dc-Defibrillator, Low-Energy, (Including Paddles)
Cardiovascular · 21 CFR 870.5300 · Class 2
Overview
| Product Code | LDD |
|---|---|
| Device Name | Dc-Defibrillator, Low-Energy, (Including Paddles) |
| Regulation | 21 CFR 870.5300 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Identification
Low-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. High-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.
Classification Rationale
Low-energy DC-defibrillator: Class II (performance standards). High-energy DC-defibrillator: Class III (premarket approval).
Recent Cleared Devices (20 of 166)
Showing 20 most recent of 166 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203231 | Switched Internal Paddles | Philips North America, LLC | Jan 11, 2021 | SESE |
| K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | Jul 24, 2020 | SESE |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | Physio-Control, Inc. | Jun 3, 2019 | SESE |
| K150349 | Rapid Hair Removal Pads | Full Power Aed | Jul 14, 2015 | SESE |
| K140502 | ZOLL E SERIES ALS | ZOLL Medical Corporation | Nov 6, 2014 | SESE |
| K103651 | CARDIOMED | Cardio Medical Products, Inc. | Oct 4, 2011 | SESE |
| K103783 | EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC | Fiab Spa | Jun 16, 2011 | SESE |
| K103334 | CARDIO MED | Cardio Medical Products, Inc. | Jan 18, 2011 | SESE |
| K103159 | CARDIO MED MODEL A102, H104, O101, P103, AND Z100 | Cardio Medical Products, Inc. | Jan 11, 2011 | SESE |
| K102468 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | Sep 30, 2010 | SESE |
| K100654 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | Jul 29, 2010 | SESE |
| K081442 | HEART SYNC PEDIATRIC, MODEL PED-100 | Heart Sync, LLC | Sep 24, 2008 | SESE |
| K081574 | ZOLL R SERIES | ZOLL Medical Corporation | Sep 18, 2008 | SESE |
| K042302 | ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE | Zoll Medical Corp | Oct 26, 2004 | SESE |
| K032691 | ZOLL AUTOCLAVABLE INTERNAL HANDLES | Zoll Medical Corp | Nov 13, 2003 | SESE |
| K030417 | DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES | Philips Medical Systems | May 9, 2003 | SESE |
| K011461 | ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR | Access Cardiosystems, Inc. | May 28, 2002 | SESE |
| K012274 | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER | Medtronic Physio-Control Corp. | Feb 5, 2002 | SESE |
| K993205 | BOOKER BOX, MODEL PAD 5010 | Tz Medical, Inc. | Jul 20, 2000 | SESE |
| K982896 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 | Alexander Mfg. Co. | Oct 21, 1998 | ST |
Top Applicants
- Physio-Control Corp. — 15 clearances
- Cardiotronics, Inc. — 14 clearances
- Nihon Kohden America, Inc. — 8 clearances
- Zoll Medical Corp — 7 clearances
- Marquette Electronics, Inc. — 7 clearances
