Clearance Summary
LIFEPAK 15 AC Power Adapter (41577-000333) received FDA 510(k) clearance under submission number K253099, sponsored by Physio-Control, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-10-14.
- Submission: K253099
- Applicant / Sponsor: Physio-Control, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5300
- Decision date: 2025-10-14
Classification & Regulation
This clearance is catalogued under FDA product code MPD and 21 CFR 870.5300, within the Cardiovascular review panel as a Class II device.