Cleared Special

K253099 - LIFEPAK 15 AC Power Adapter (41577-000333) (FDA 510(k) Clearance)

Oct 2025
Decision
20d
Days
Class 2
Risk

K253099 is an FDA 510(k) clearance for the LIFEPAK 15 AC Power Adapter (41577-000333). This device is classified as 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 FDA review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number K253099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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

Device Classification

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