ClearanceBrief
510(k) K142430 ยท MKJ Automated External Defibrillators (Non-Wearable)

LIFEPAK 15 monitor/defibrillator

ApplicantPhysio-Control, Inc., Redmond WA, US
DecisionSubstantially Equivalent, Dec 19, 2014
ReceivedAug 29, 2014
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K142430

DateFirm and productCodeLinked 510(k)
Dec 20, 2019Physio-Control, Inc.
LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
Terminated		 MKJNone listed
Dec 20, 2019Physio-Control, Inc.
LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Terminated		 MKJNone listed
Feb 26, 2019Physio-Control Inc
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life
Terminated		 MKJNone listed
Feb 26, 2019Physio-Control Inc
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and
Terminated		 MKJNone listed
Feb 11, 2017Physio-Control, Inc.
LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is
Terminated		 MKJNone listed
Jan 16, 2017Physio-Control, Inc.
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions sp
Terminated		 MKJNone listed
Jun 15, 2016Physio-Control, Inc.
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The
Terminated		 MKJNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.