DeviceClearance

Product code MKJ— Cardiovascular

ZOLL X SERIES

Classification name
Automated External Defibrillators (Non-Wearable)
Device class
Class 3
Regulation
21 CFR 870.5310
Advisory panel
Cardiovascular
Total cleared
228
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code MKJ under 21 CFR 870.5310, via openFDA

Market context for product code MKJ

FDA has cleared 228 devices under product code MKJ between 1985 and 2015, filed by 51 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

Clearances per year

last 15 years

Top applicants under product code MKJ

Adverse events under product code MKJ

product code MKJ
Death
961
Injury
1,070
Malfunction
90,719
Other
8
Total
92,758

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MKJ

1–100 of 228

Data sourced from openFDA. This site is unofficial and independent of the FDA.