MPD · Class II · 21 CFR 870.5300

FDA Product Code MPD: Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator

Leading manufacturers include Stryker Physio-Control and Physio-Control, Inc..

3
Total
3
Cleared
147d
Avg days
2007
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 20d recently vs 211d historically

FDA 510(k) Cleared Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator Devices (Product Code MPD)

3 devices
1–3 of 3

About Product Code MPD - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code MPD since 2007, with 3 receiving FDA clearance (average review time: 147 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA Review Time

Recent submissions under MPD have taken an average of 20 days to reach a decision - down from 211 days historically, suggesting improved FDA processing for this classification.

MPD devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →