Product code MKJ: 510(k) clearances and predicates
Product code MKJ covers Powerheart G5 AED. FDA lists 228 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
228 clearances on file under product code MKJ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest MKJ clearances in the FDA index, with applicant and decision date:
- K143714, Powerheart G5 AED, applicant Cardiac Science Corporation, decided 2015-05-04. FDA record
- K150198, CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel, applicant Bio-Detek, Inc., decided 2015-05-02. FDA record
- K150055, OneStep Pediatric CPR Multi-Function Electrode, applicant Bio-Detek, Inc., decided 2015-05-02. FDA record
- K142709, samaritan PAD 450P, applicant Heartsine Technologies, Inc., decided 2015-03-27. FDA record
- K133659, HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING, applicant Philips Medical Systems, decided 2015-01-23. FDA record
- K133239, ZOLL E SERIES, applicant Zoll Medical Corporation, World Wide Headquarters, decided 2015-01-16. FDA record
- K142430, LIFEPAK 15 monitor/defibrillator, applicant Physio-Control, Inc., decided 2014-12-19. FDA record
- K141795, BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500, applicant R & D Batteries, Inc., decided 2014-12-08. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel, OneStep Pediatric CPR Multi-Function Electrode. Watch new MKJ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code MKJ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MKJ clearances include Powerheart G5 AED.
How many 510(k) clearances use product code MKJ?
228 at the time this page was generated, from openFDA records.
How do I find a predicate device under MKJ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new MKJ clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.