Automated External Defibrillators (Non-Wearable)

What Is It?

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.

How Is MKJ Classified?

Automated External Defibrillators (Non-Wearable) is FDA product code MKJ, Class 3, 21 CFR 870.5310.

How Does It Reach the US Market?

A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.

What Do the Recalls Say?

The FDA has recorded 335 recalls under this product code since 2002. None was by a company in China. 27 are Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (66), Process control (62) and Device Design (52). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.