FDA product code MKJ: Automated External Defibrillators (Non-Wearable)
MKJ is the FDA product code for automated external defibrillators (non-wearable). It is a Class III device, regulated under 21 CFR 870.5310 and reviewed by the Cardiovascular panel. FDA has cleared 228 510(k) submissions under MKJ, from 51 different applicants. The average 510(k) review took 156 days (median 132). 17 PMA applications cite this product code. FDA has posted 336 recalls for MKJ devices, 49 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Automated External Defibrillators (Non-Wearable) |
| Device class | Class III |
| Regulation | 21 CFR 870.5310 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
Compare with all 510(k) review times · Search every MKJ clearance
Top MKJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zoll Medical Corp | 19 | 2014-08-01 |
| Zoll Medical Corporation, World Wide Headquarters | 17 | 2015-01-16 |
| Philips Medical Systems | 16 | 2015-01-23 |
| ZOLL Medical Corporation | 16 | 2014-12-03 |
| Physio-Control Corp. | 11 | 1999-09-03 |
46 more applicants have MKJ clearances. See the full list in Caduvo.
Most recent MKJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143714 | Cardiac Science Corporation | Powerheart G5 AED | 2015-05-04 | 126 |
| K150055 | Bio-Detek, Inc. | OneStep Pediatric CPR Multi-Function Electrode | 2015-05-02 | 110 |
| K150198 | Bio-Detek, Inc. | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | 2015-05-02 | 93 |
| K142709 | Heartsine Technologies, Inc. | samaritan PAD 450P | 2015-03-27 | 186 |
| K133659 | Philips Medical Systems | HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING | 2015-01-23 | 422 |
Recalls for MKJ devices
336 product recalls in 216 recall events; 49 initiated in the last five years and 54 still open. Most recent: 2026-07-27.
| Year | Recalls |
|---|---|
| 2017 | 12 |
| 2018 | 12 |
| 2019 | 12 |
| 2020 | 16 |
| 2021 | 6 |
| 2022 | 3 |
| 2023 | 14 |
| 2024 | 8 |
| 2025 | 20 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code MKJ?
MKJ is the FDA product code for automated external defibrillators (non-wearable). It is a Class III device, regulated under 21 CFR 870.5310 and reviewed by the Cardiovascular panel.
What device class is MKJ?
Class III, regulation 21 CFR 870.5310. Typical premarket route: PMA.
How long does a 510(k) take for product code MKJ?
Across 228 cleared submissions the average was 156 days from receipt to decision (median 132).
Which companies have the most MKJ clearances?
Zoll Medical Corp (19); Zoll Medical Corporation, World Wide Headquarters (17); Philips Medical Systems (16); ZOLL Medical Corporation (16); Physio-Control Corp. (11).
Have MKJ devices been recalled?
Yes: 336 product recalls across 216 recall events; the most recent began 2026-07-27.
Next steps
- Run an FDA pathway report with predicate devices for product code MKJ
- Run a recall and safety report across every MKJ manufacturer
- Watch product code MKJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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