Cleared Special

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

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253099 · Physio-Control, Inc. · Cardiovascular device
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Oct 2025
Decision
20d
Days
Class 2
Risk

K253099 is an FDA 510(k) clearance for the LIFEPAK 15 AC Power Adapter (41577-000333). Classified as Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator (product code MPD), Class II - Special Controls.

Submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on October 14, 2025 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Physio-Control, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MPD Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.