Physio-Control, Inc. · Class II · Cleared Oct 14, 2025
| K-number | K253099 |
| Device name | LIFEPAK 15 AC Power Adapter (41577-000333) |
| Applicant | Physio-Control, Inc. |
| Product code | MPD |
| Device class | Class II |
| Decision date | Oct 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.5300 |
The LIFEPAK 15 AC Power Adapter is an optional accessory that connects to the LIFEPAK 15 monitor/defibrillator to provide auxiliary AC power for operation and battery charging. It includes a bracket and screws for wall or shelf mounting and is intended for use in hospital environments and ground transport vehicles.
The device has an input rating of 100–240 VAC at 50/60/400 Hz with 1.8 A, and outputs 11.0–14.0 Volts at 7 A DC (or at least 6.5 A above 40°C). It features a 9.331-inch cable, operates from 0–45°C, has IP32 dust and water resistance, and meets IEC 60601-1, IEC 60601-1-2, IEC 60601-1-12, and IEC 60601-2-4 standards.
Electrical Safety and Electromagnetic Compatibility Testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-12, and IEC 60601-2-4; Design Verification Testing.
The LIFEPAK 15 AC Power Adapter is substantially equivalent to the predicate LIFEPAK 35 AC Power Adapter because both devices serve the same intended use as auxiliary power supplies for their respective monitor/defibrillators, share identical input voltage ratings, operating conditions, and safety classifications, and differ only in output voltage/amperage and cable length to match their respective device compatibility.
View the full FDA submission: accessdata.fda.gov