FDA product code MPE: Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
MPE is the FDA product code for auxiliary power supply (acor dc) for external transcutaneous cardiac pacemaker. It is a Class II device, regulated under 21 CFR 870.5550 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under MPE. The average 510(k) review took 321 days (median 321).
Classification
| Field | Value |
|---|---|
| Device name | Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker |
| Device class | Class II |
| Regulation | 21 CFR 870.5550 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every MPE clearance
Top MPE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Physio-Control Corp. | 1 | 1995-09-26 |
Most recent MPE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945511 | Physio-Control Corp. | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR | 1995-09-26 | 321 |
Recalls for MPE devices
openFDA lists no recalls for product code MPE.
Frequently asked questions
What is FDA product code MPE?
MPE is the FDA product code for auxiliary power supply (acor dc) for external transcutaneous cardiac pacemaker. It is a Class II device, regulated under 21 CFR 870.5550 and reviewed by the Cardiovascular panel.
What device class is MPE?
Class II, regulation 21 CFR 870.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code MPE?
Across 1 cleared submissions the average was 321 days from receipt to decision (median 321).
Which companies have the most MPE clearances?
Physio-Control Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MPE
- Run a recall and safety report across every MPE manufacturer
- Watch product code MPE 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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