510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MKJClass III

Automated External Defibrillators (Non-Wearable)

21 CFR 870.5310 / Cardiovascular
FDA source (opens on fda.gov)

MKJ is the FDA product code for Automated External Defibrillators (Non-Wearable), a class III device type, regulated under 21 CFR 870.5310. FDA's definition for this code reads: "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...". As of , FDA records hold 228 510(k) clearances under this code, the most recent dated , and 335 recalls.

Classification record

Product code
MKJ
Device name
Automated External Defibrillators (Non-Wearable)
FDA 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.
Regulation
21 CFR 870.5310
Device class
Class III
Review panel
Cardiovascular
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
228
Ingested recalls
336

Clearances, product code MKJ

By decision year
228 clearances under product code MKJ with a decision year between 1985 and 2015, 2004 the highest year at 18.
Show the numbers
510(k) clearances under FDA product code MKJ by decision year
YearClearances
19851
19861
19871
19884
19892
19901
19933
19944
19957
19969
199710
199811
199912
200010
200114
200217
20038
200418
20059
20069
20077
200813
20098
20104
201111
201210
20137
201411
20156

Applicants with the most clearances

Product code MKJ
Applicants holding the most 510(k) clearances under product code MKJ
ApplicantClearances
ZOLL Medical Corporation79
Physio Control, Inc.30
Philips North America LLC18
Defibtech LLC7
Katecho LLC7
Medical Research Laboratories, Inc.7
Graphic Controls Corp.6
HeartSine Technologies Ltd6
Hewlett-Packard Co.6
Survivalink Corp.6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 59 companies shown, in name order