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FDA PRODUCT CODE · CLASS III

MKJ — Automated External Defibrillators (Non-Wearable)

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.

DEVICE CLASS
Class III
REGULATION
21 CFR 870.5310
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
12
510(K)/PMA CLEARANCES
pma: 12
0
RECALL ENTRIES

Recent clearances

P160015ZOLL Medical Corporation · pma2026-07-16
P160022ZOLL Medical Corporation · pma2026-07-14
P160026Physio-Control, Inc. · pma2026-06-25
P160032Defibtech, LLC · pma2026-06-25
P160008Heartsine Technologies, Ltd. · pma2026-06-22
P160028Philips Medical Systems, Inc. · pma2026-05-21
P180028Philips Medical Systems · pma2026-05-21
P160033ZOLL Medical Corporation · pma2026-04-28

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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