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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K253099

510(k) cleared

LIFEPAK 15 AC Power Adapter (41577-000333)

Physio-Control, Inc. · Oct 14, 2025 · K253099

FDA cleared the LIFEPAK 15 AC Power Adapter (41577-000333) from Physio-Control, Inc. on Oct 14, 2025 under K253099, a special 510(k). The device falls under product code MPD, Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator, regulated at 21 CFR 870.5300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 24, 2025. The decision came 20 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Physio-Control, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253099?

K253099 is the FDA 510(k) for LIFEPAK 15 AC Power Adapter (41577-000333), submitted by Physio-Control, Inc.. FDA's decision date was Oct 14, 2025, under product code MPD (Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator).

Who makes the LIFEPAK 15 AC Power Adapter (41577-000333)?

Physio-Control, Inc., based in Redmond, WA, is the applicant of record for K253099.

How long did the K253099 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Oct 14, 2025, 20 days later.

← All decisions in October 2025