Submission Details
| 510(k) Number | K253099 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 24, 2025 |
| Decision Date | October 14, 2025 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
K253099 is an FDA 510(k) clearance for the LIFEPAK 15 AC Power Adapter (41577-000333), a Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator (Class II — Special Controls, product code MPD), submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on October 14, 2025, 20 days after receiving the submission on September 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.
| 510(k) Number | K253099 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 24, 2025 |
| Decision Date | October 14, 2025 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MPD — Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5300 |