Physio-Control, Inc. - FDA 510(k) Cleared Devices
Recent clearances: LIFEPAK 15 AC Power Adapter (41577-000333), LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021), Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Physio-Control, Inc. Cardiovascular ✕
14 devices
Cleared
Oct 14, 2025
LIFEPAK 15 AC Power Adapter (41577-000333)
Cardiovascular
20d
Cleared
Apr 30, 2024
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical...
Cardiovascular
102d
Cleared
Jun 03, 2019
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK...
Cardiovascular
264d
Cleared
Dec 19, 2014
LIFEPAK 15 monitor/defibrillator
Cardiovascular
112d
Cleared
Aug 21, 2013
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
Cardiovascular
180d
Cleared
Apr 17, 2013
TRUECPR COACHING DEVICE
Cardiovascular
147d
Cleared
Oct 11, 2012
LIFEPAK 1000 DEFIBRILLATOR
Cardiovascular
45d
Cleared
Mar 22, 2011
LIFEPAK 15 MONITOR/DEFIBRILLATOR
Cardiovascular
106d
Cleared
Dec 22, 2010
LIFEPAK 12
Cardiovascular
77d
Cleared
Nov 05, 2010
LIFENET SYSTEM
Cardiovascular
43d
Cleared
Jan 12, 2010
LIFENET SYSTEM
Cardiovascular
21d
Cleared
Mar 11, 2009
LIFEPAK 15 MONITOR/DEFIBRILLATOR
Cardiovascular
161d
Cleared
Jul 29, 2008
LIFEPAK 20E
Cardiovascular
271d
Cleared
Oct 26, 1984
PERSONAL DEFIBRILLATOR
Cardiovascular
434d