Over-The-Counter Automated External Defibrillator
FDA product code NSA · Class III (high risk) · 21 CFR 870.5310 · Cardiovascular
Automated external defibrillators are devices that 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 over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs.
1510(k) clearances
1PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040904 | Philips Heartstart Home Defibrillator, Model M5068ANSA · Traditional | Philips Medical Systems | 09/16/2004SE |
PMA approvals
- P160029 HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) · Philips Medical Systems, Inc. · 06/06/2019
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1196-2010 | Heartstart HS1 Defibrillator Model M5068APotential for failure of a capacitor during use which would prevent the AED from delivering effective… | Philips Medical Systems | 11/02/2009Terminated |
| Z-1781-2008 | Philips "HeartStart Home" defibrillator, model M5068A and is sold in the US over the…Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when… | Philips Medical Systems | 04/30/2008Terminated |