Physio-Control, Inc.

• MKJ — Cardiovascular7 devices
• LDD — Cardiovascular2 devices
• MSX — Cardiovascular2 devices
• DSA — Cardiovascular1 device
• LIX — Cardiovascular1 device
• MPD — Cardiovascular1 device

• Z-2065-2026 — LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122Class II·Ongoing·2026-04-13
• Z-1544-2026 — PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).Class II·Ongoing·2026-01-21
• Z-2497-2025 — LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.Class II·Ongoing·2025-07-22
• Z-2498-2025 — LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.Class II·Ongoing·2025-07-22
• Z-2499-2025 — LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.Class II·Ongoing·2025-07-22
• Z-1232-2025 — LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.Class II·Ongoing·2025-02-03
• Z-1184-2025 — LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF 11996-000520 The LIFEPAK¿ 15 Monitor/Defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. RD rainbow" 8¿ SpCO sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO¿), and methemoglobin saturation (SpMet¿) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.Class II·Ongoing·2025-01-21
• Z-1102-2025 — LIFEPAK 35 ECG cable REF 11111-000041Class II·Ongoing·2025-01-21
• Z-0230-2025 — LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.Class II·Ongoing·2024-08-30
• Z-0142-2025 — STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.Class II·Ongoing·2024-08-09

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K253099 — LIFEPAK 15 AC Power Adapter (41577-000333)Code MPD·2025-10-14
• K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021) +1 moreCode DSA·2024-04-30
• K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsCode LDD·2019-06-03
• K142430 — LIFEPAK 15 monitor/defibrillatorCode MKJ·2014-12-19
• K130454 — LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORCode MKJ·2013-08-21
• K123597 — TRUECPR COACHING DEVICECode LIX·2013-04-17
• K122600 — LIFEPAK 1000 DEFIBRILLATORCode MKJ·2012-10-11
• K103567 — LIFEPAK 15 MONITOR/DEFIBRILLATORCode MKJ·2011-03-22
• K102972 — LIFEPAK 12Code MKJ·2010-12-22
• K102757 — LIFENET SYSTEMCode MSX·2010-11-05
• K093925 — LIFENET SYSTEMCode MSX·2010-01-12
• K082937 — LIFEPAK 15 MONITOR/DEFIBRILLATORCode MKJ·2009-03-11
• K073089 — LIFEPAK 20ECode MKJ·2008-07-29
• K832833 — PERSONAL DEFIBRILLATORCode LDD·1984-10-26