Data / Medical devices / Automated External Defibrillators (Non-Wearable)

Automated External Defibrillators (Non-Wearable) (MKJ): 37 FDA-registered makers in 10 countries

37 establishments in 10 countries are registered with the FDA to make Automated External Defibrillators (Non-Wearable) (product code MKJ, Class 3, 21 CFR 870.5310). 19 of them have a 510(k) clearance or PMA approval on file and 10 have a recall event. The FDA has issued 228 510(k) clearances under this code, the latest on May 4, 2015, and lists 216 recall events (14 Class I). FDA data exported November 2, 2026.

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Product code

MKJ

Device class

3

Regulation

870.5310

Medical specialty

Cardiovascular

Makers by country

Makers of Automated External Defibrillators (Non-Wearable)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated May 4, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.