Home / Companies / Physio-Control, Inc.

Physio-Control, Inc.

FDA Regulatory Profile

Summary

Total Recalls
40 (7 Class I)
510(k) Clearances
94
Inspections
13
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1544-2026Class IIPHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 January 21, 2026
Z-2498-2025Class IILIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 3203July 22, 2025
Z-2499-2025Class IILIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAJuly 22, 2025
Z-2497-2025Class IILIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2July 22, 2025
Z-1232-2025Class IILIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arresFebruary 3, 2025
Z-1102-2025Class IILIFEPAK 35 ECG cable REF 11111-000041January 21, 2025
Z-1184-2025Class IILIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult AdheJanuary 21, 2025
Z-0230-2025Class IILIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-00August 30, 2024
Z-0142-2025Class IISTERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES August 9, 2024
Z-0567-2024Class IIAC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098November 6, 2023
Z-0305-2024Class IILIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026September 29, 2023
Z-0296-2024Class IILIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051September 29, 2023
Z-0302-2024Class IILIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021September 29, 2023
Z-0298-2024Class IILIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067September 29, 2023
Z-0301-2024Class IILIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020September 29, 2023
Z-0297-2024Class IILIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061September 29, 2023
Z-0299-2024Class IILIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602September 29, 2023
Z-0304-2024Class IILIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023September 29, 2023
Z-0300-2024Class IILIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002September 29, 2023
Z-0303-2024Class IILIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022September 29, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K253099LIFEPAK 15 AC Power Adapter (41577-000333)October 14, 2025
K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive PressureApril 30, 2024
K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsJune 3, 2019
K142430LIFEPAK 15 monitor/defibrillatorDecember 19, 2014
K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORAugust 21, 2013
K123597TRUECPR COACHING DEVICEApril 17, 2013
K122600LIFEPAK 1000 DEFIBRILLATOROctober 11, 2012
K103567LIFEPAK 15 MONITOR/DEFIBRILLATORMarch 22, 2011
K102972LIFEPAK 12December 22, 2010
K102757LIFENET SYSTEMNovember 5, 2010
K093925LIFENET SYSTEMJanuary 12, 2010
K082937LIFEPAK 15 MONITOR/DEFIBRILLATORMarch 11, 2009
K073089LIFEPAK 20EJuly 29, 2008
K991910LIFEPAK 12 BIPHASICSeptember 3, 1999
K990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMSeptember 1, 1999
K983393LIFEPAK 500 BIPHASICMay 5, 1999
K973486LIFE PAK 12January 9, 1998
K962359LIFEPAK 300November 6, 1997
K955854LIFEPAK 500November 4, 1996
K953204PEDIATRIC QUIK-COMBOJanuary 11, 1996