FDA product code · Cardiovascular
MKJAutomated External Defibrillators (Non-Wearable)
Product code MKJ covers Automated External Defibrillators (Non-Wearable), a Class III device regulated under 21 CFR 870.5310. FDA has cleared 228 devices in this code. Median review time across the 228 most recent decisions is 131 days. openFDA lists 334 recall records against this code.
Updated · ingest status · JSON
- Class
- Class III
- Regulation
- 21 CFR 870.5310
- Review panel
- Cardiovascular
- Clearances
- 228
What is happening in MKJ right now?
MKJ (Automated External Defibrillators (Non-Wearable)) has one finding. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2065-2026, Z-1544-2026, Z-0288-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2065-2026, Z-1544-2026, Z-0288-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code MKJ cover?
MKJ is FDA's product code for Automated External Defibrillators (Non-Wearable), a Class III device regulated under 21 CFR 870.5310.
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.
Source: openFDA device/classification · record MKJ · retrieved
How many devices has FDA cleared in MKJ?
FDA has cleared 228 devices under product code MKJ since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143714 | Powerheart G5 AED | Cardiac Science Corporation | |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | Bio-Detek, Inc. | |
| K150055 | OneStep Pediatric CPR Multi-Function Electrode | Bio-Detek, Inc. | |
| K142709 | samaritan PAD 450P | Heartsine Technologies, Inc. | |
| K133659 | HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING | Philips Medical Systems | |
| K133239 | ZOLL E SERIES | Zoll Medical Corporation, World Wide Headquarters | |
| K142430 | LIFEPAK 15 monitor/defibrillator | Physio-Control, Inc. | |
| K141795 | BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 | R & D Batteries, Inc. | |
| K142915 | ZOLL X Series | ZOLL Medical Corporation | |
| K142803 | Skintact, various other tradenames | Leonhard Lang GmbH |
How long does FDA review take for MKJ?
The median FDA review time for MKJ is 131 days, measured across the 228 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in MKJ?
openFDA lists 334 recall records against product code MKJ. A recall record covers one firm's corrective action and may span many device lots.
Z-2065-2026Open, ClassifiedPhysio-Control, Inc.
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
Z-1544-2026Open, ClassifiedPhysio-Control, Inc.
Due to pediatric defibrillator electrode delamination
Z-0288-2026Open, ClassifiedHeartsine Technologies, Limited
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
Z-2497-2025Open, ClassifiedPhysio-Control, Inc.
Due to required inspections not being performed on products/units that have gone through servicing.
Z-2498-2025Open, ClassifiedPhysio-Control, Inc.
Due to required inspections not being performed on products/units that have gone through servicing.
Showing the 5 most recently initiated of 334. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for MKJ?
MAUDE holds 41,401 adverse-event reports naming product code MKJ, 8,580 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in MKJ unusual?
Every month with enough history behind it falls inside MKJ's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 925 | Insufficient history | No expected range — too little history | |
| 1,150 | Insufficient history | No expected range — too little history | |
| 1,344 | Insufficient history | No expected range — too little history | |
| 1,062 | Insufficient history | No expected range — too little history | |
| 1,178 | Insufficient history | No expected range — too little history | |
| 1,135 | Insufficient history | No expected range — too little history | |
| 996 | Insufficient history | No expected range — too little history | |
| 1,087 | Insufficient history | No expected range — too little history | |
| 1,008 | Insufficient history | No expected range — too little history | |
| 1,160 | Insufficient history | No expected range — too little history | |
| 1,249 | Insufficient history | No expected range — too little history | |
| 1,165 | Insufficient history | No expected range — too little history | |
| 1,717 | Insufficient history | No expected range — too little history | |
| 1,407 | Insufficient history | No expected range — too little history | |
| 1,168 | Insufficient history | No expected range — too little history | |
| 1,317 | Insufficient history | No expected range — too little history | |
| 1,239 | Insufficient history | No expected range — too little history | |
| 1,135 | Insufficient history | No expected range — too little history | |
| 1,279 | Insufficient history | No expected range — too little history | |
| 1,085 | Insufficient history | No expected range — too little history | |
| 1,192 | Insufficient history | No expected range — too little history | |
| 948 | 697–1,486 | Within expected (697–1,486) | |
| 926 | 550–1,279 | Within expected (550–1,279) | |
| 1,021 | 615–1,438 | Within expected (615–1,438) | |
| 1,054 | 637–1,497 | Within expected (637–1,497) | |
| 999 | 802–1,181 | Within expected (802–1,181) | |
| 1,023 | 889–1,169 | Within expected (889–1,169) | |
| 1,156 | 1,456–1,771 | Below expected (1,456–1,771) | |
| 1,150 | 894–1,336 | Within expected (894–1,336) | |
| 1,166 | 957–1,410 | Within expected (957–1,410) | |
| 1,191 | 945–1,398 | Within expected (945–1,398) | |
| 996 | 866–1,253 | Within expected (866–1,253) | |
| 1,375 | 931–1,377 | Within expected (931–1,377) | |
| 996 | 1,130–1,682 | Below expected (1,130–1,682) | |
| 1,026 | 784–1,390 | Within expected (784–1,390) | |
| 1,029 | 839–1,504 | Within expected (839–1,504) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in MKJ.
What are the predicate devices in MKJ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in MKJ?
Across the 228 most recent decisions, these applicants filed most often in MKJ.
| Applicant | Recent clearances |
|---|---|
| Zoll Medical Corp | 19 |
| Zoll Medical Corporation, World Wide Headquarters | 17 |
| Philips Medical Systems | 16 |
| ZOLL Medical Corporation | 16 |
| Physio-Control Corp. | 11 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
4 companies in MKJ file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| ZOLL Medical Corporation | 35 | 2 |
| Physio-Control, Inc. | 18 | 2 |
| Cardiac Science Corporation | 17 | 3 |
| Philips Medical Systems, Inc. | 17 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch MKJ
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.