Atlas FDA

LIFEPAKAutomated External Defibrillators (AEDs)

FDA premarket approval P160026/S016 · decided 2020-07-28

Approval details

PMA number
P160026
Supplement
S016
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
LIFEPAKAutomated External Defibrillators (AEDs)
Generic name
Automated external defibrillators (non-wearable)
Applicant
Physio-Control, Inc.
Date received
2020-05-01
Decision date
2020-07-28
Days to decision
88 days
Decision code
APPR
Product code
MKJ
Advisory committee
Cardiovascular
Expedited review
No
Location
Redmond, WA
Statement
Approval for design changes related to the System Printed Circuit Board Assembly (PCBA) component of the LIFEPAK 15 monitor/defibrillator and additional design improvements.

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510(k) clearances by this applicant

RecordFirmDate
LIFEPAK 15 AC Power Adapter (41577-000333) (K253099)Physio-Control, Inc.2025-10-14
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) (K240156)Physio-Control, Inc.2024-04-30
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors (K182503)Physio-Control, Inc.2019-06-03
LIFEPAK 15 monitor/defibrillator (K142430)Physio-Control, Inc.2014-12-19
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR (K130454)Physio-Control, Inc.2013-08-21
TRUECPR COACHING DEVICE (K123597)Physio-Control, Inc.2013-04-17
LIFEPAK 1000 DEFIBRILLATOR (K122600)Physio-Control, Inc.2012-10-11
LIFEPAK 15 MONITOR/DEFIBRILLATOR (K103567)Physio-Control, Inc.2011-03-22