Physio Control, Inc.
Redmond, WA, US
PHYSIO-CONTROL, INC. appears in FDA device records in Redmond, WA. FDA records list 108 510(k) clearances between and , 101 PMA records and one registered establishment. As of , FDA records show 100 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Physio Control, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medtronic Emergency Response Systems, Inc.510(k), recall
- Medtronic Physio-Control Corp.510(k), recall
510(k) clearance history
Showing 50 of 108FDA records hold 108 510(k) clearances for Physio Control, Inc. between 1976 and 2025. The busiest year on record is 1976, with 9. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 9 |
| 1977 | 5 |
| 1978 | 3 |
| 1979 | 6 |
| 1980 | 2 |
| 1981 | 1 |
| 1983 | 2 |
| 1984 | 7 |
| 1985 | 6 |
| 1986 | 6 |
| 1987 | 2 |
| 1988 | 5 |
| 1989 | 4 |
| 1990 | 3 |
| 1991 | 3 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 3 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 3 |
| 2001 | 4 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2019 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | MPD | Substantially Equivalent | |
| K240156 | 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) | DSA | Substantially Equivalent | |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | LDD | Substantially Equivalent | |
| K142430 | LIFEPAK 15 monitor/defibrillator | MKJ | Substantially Equivalent | |
| K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR | MKJ | Substantially Equivalent | |
| K123597 | TRUECPR COACHING DEVICE | LIX | Substantially Equivalent | |
| K122600 | LIFEPAK 1000 DEFIBRILLATOR | MKJ | Substantially Equivalent | |
| K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | MKJ | Substantially Equivalent | |
| K102972 | LIFEPAK 12 | MKJ | Substantially Equivalent | |
| K102757 | LIFENET SYSTEM | MSX | Substantially Equivalent | |
| K093925 | LIFENET SYSTEM | MSX | Substantially Equivalent | |
| K082937 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | MKJ | Substantially Equivalent | |
| K073089 | LIFEPAK 20E | MKJ | Substantially Equivalent | |
| K063510 | LIFEPAK 12 DEFIBRILLATOR/MONITOR | MKJ | Substantially Equivalent | |
| K063119 | LIFEPAK 20 DEFIBRILLATOR/ MONITOR | MKJ | Substantially Equivalent | |
| K052057 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | Substantially Equivalent | |
| K052854 | LIFENET EXCHANGE SYSTEM | MSX | Substantially Equivalent | |
| K042404 | LIFEPAK, MODEL 1000 | MKJ | Substantially Equivalent | |
| K041459 | LIFEPAK 12 DEFIBRILLATOR/MONITOR | MKJ | Substantially Equivalent | |
| K040775 | LIFEPAK 12 | MKJ | Substantially Equivalent | |
| K033275 | LIFEPAK 12, 20, 500, CR PLUS | MKJ | Substantially Equivalent | |
| K022732 | INFANT/CHILD REDUCED ENERGY ELECTRODES | MKJ | Substantially Equivalent | |
| K012274 | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER | LDD | Substantially Equivalent | |
| K011144 | LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | Substantially Equivalent | |
| K012428 | MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | Substantially Equivalent | |
| K010918 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM | MKJ | Substantially Equivalent - Subject to Tracking Reg. | |
| K002445 | LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES | MKJ | Substantially Equivalent - Subject to Tracking Reg. | |
| K991910 | LIFEPAK 12 BIPHASIC | MKJ | Substantially Equivalent - Subject to Tracking Reg. | |
| K990338 | NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM | DXN | Substantially Equivalent | |
| K983393 | LIFEPAK 500 BIPHASIC | MKJ | Substantially Equivalent - Subject to Tracking Reg. | |
| K973486 | LIFE PAK 12 | MKJ | Substantially Equivalent | |
| K962359 | LIFEPAK 300 | MKJ | Substantially Equivalent | |
| K955854 | LIFEPAK 500 | MKJ | Substantially Equivalent | |
| K953204 | PEDIATRIC QUIK-COMBO | MKJ | Substantially Equivalent | |
| K951593 | LIFEPAK 11 | DRO | Substantially Equivalent | |
| K945511 | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR | MPE | Substantially Equivalent | |
| K943301 | QUIK COMBO | DRX | Substantially Equivalent | |
| K941970 | FAST-PATCH | MKJ | Substantially Equivalent | |
| K925936 | LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR | MKJ | Substantially Equivalent | |
| K922315 | VITAL-COMBO(R) | LDD | Substantially Equivalent | |
| K935674 | LIFEPAK 9 DEFIBRILLATOR/MONITOR | LDD | Substantially Equivalent | |
| K931053 | LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER | LDD | Substantially Equivalent | |
| K912966 | PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG | LDD | Substantially Equivalent | |
| K912189 | LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 REC STATION | LOS | Substantially Equivalent | |
| K912599 | QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC | DRO | Substantially Equivalent | |
| K910144 | 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON | LDD | Substantially Equivalent | |
| K902288 | MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR | LDD | Substantially Equivalent | |
| K905510 | LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED | LDD | Substantially Equivalent | |
| K902478 | LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR | LDD | Substantially Equivalent | |
| K895379 | LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) | LDD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015876 | 3015876 | PHYSIO-CONTROL, INC. | 11811 WILLOWS RD., N.E., Redmond, WA 98052 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DRWAdaptor, Lead Switching, Electrocardiograph
- LIXAid, Cardiopulmonary Resuscitation
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- MKJAutomated External Defibrillators (Non-Wearable)
- MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
- MPEAuxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- DRMCompressor, Cardiac, External
- DSKComputer, Blood-Pressure
- FLLContinuous Measurement Thermometer
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DPSElectrocardiograph
- DRXElectrode, Electrocardiograph
- GYEEncephalogram Telemetry System
- EKXHandpiece, Direct Drive, Ac-Powered
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube
- DQAOximeter
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- PXDPrep Kit
- DSHRecorder, Magnetic Tape, Medical
- DSFRecorder, Paper Chart
- KDJSet, Administration, For Peritoneal Dialysis, Disposable
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- MSXSystem, Network And Communication, Physiological Monitors
- FKXSystem, Peritoneal, Automatic Delivery
- DRLTester, Defibrillator
- DJCThin Layer Chromatography, Methamphetamine
- DXOTransducer, Pressure, Catheter Tip
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- IOLTreadmill, Powered
Recall records
Showing 25 of 100| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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: 99507-000122 | Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy. | Class II | Open, Classified | |
| 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). | Due to pediatric defibrillator electrode delamination | Class II | Open, Classified | |
| 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. | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Open, Classified | |
| 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. | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Open, Classified | |
| 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. | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Open, Classified | |
| Z-1232-2025 | LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest. | Incorrect keypad was incorrectly installed onto a defibrillator/monitor. | Class II | Open, Classified | |
| Z-1102-2025 | LIFEPAK 35 ECG cable REF 11111-000041 | Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions | Class II | Open, Classified | |
| 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. | Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system. | Class II | Open, Classified | |
| 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. | Due to an out of tolerance tool being used on monitor/defibrillator systems. | Class II | Open, Classified | |
| 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. | Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles. | Class II | Open, Classified | |
| Z-0567-2024 | AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098 | AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA. | Class II | Open, Classified | |
| Z-0305-2024 | LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Class II | Open, Classified | |
| Z-0304-2024 | LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Class II | Open, Classified | |
| Z-0303-2024 | LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Class II | Open, Classified | |
| Z-0302-2024 | LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Class II | Open, Classified | |
| Z-0301-2024 | LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Class II | Open, Classified | |
| Z-0300-2024 | LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Class II | Open, Classified | |
| Z-0299-2024 | LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Class II | Open, Classified | |
| Z-0298-2024 | LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Class II | Open, Classified | |
| Z-0297-2024 | LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Class II | Open, Classified | |
| Z-0296-2024 | LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 | Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Class II | Open, Classified | |
| Z-0745-2022 | HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak | Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. | Class III | Terminated | |
| Z-1189-2021 | PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. | Due to complaints received regarding missing lid magnets which may result in premature battery depletion. | Class II | Open, Classified | |
| Z-2360-2020 | Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system. | Packaging of infant child reduced energy electrodes was not properly sealed. | Class II | Terminated | |
| Z-2359-2020 | Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system. | Packaging of infant child reduced energy electrodes was not properly sealed. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain