Company · US
Physio-Control Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2025. Name variants (Inc, Corp, punctuation) are merged.
94510(k) clearances (0 in 12 months)
72recalls (2 in 12 months)
50recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 74 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 30 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 10 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 6 |
| DPS | Electrocardiograph | 5 |
| DRX | Electrode, Electrocardiograph | 5 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 |
| DSF | Recorder, Paper Chart | 3 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 |
| IOL | Treadmill, Powered | 2 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 2 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 2 |
| MSX | System, Network And Communication, Physiological Monitors | 2 |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | 1 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 |
| DQA | Oximeter | 1 |
| DRL | Tester, Defibrillator | 1 |
| DRW | Adaptor, Lead Switching, Electrocardiograph | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 14, 2025 | K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) Physio-Control, Inc. | MPD |
| Apr 30, 2024 | K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equ Physio-Control, Inc. | DSA |
| Jun 3, 2019 | K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors Physio-Control, Inc. | LDD |
| Dec 19, 2014 | K142430 | LIFEPAK 15 monitor/defibrillator Physio-Control, Inc. | MKJ |
| Aug 21, 2013 | K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR Physio-Control, Inc. | MKJ |
| Apr 17, 2013 | K123597 | TRUECPR COACHING DEVICE Physio-Control, Inc. | LIX |
| Oct 11, 2012 | K122600 | LIFEPAK 1000 DEFIBRILLATOR Physio-Control, Inc. | MKJ |
| Mar 22, 2011 | K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR Physio-Control, Inc. | MKJ |
| Dec 22, 2010 | K102972 | LIFEPAK 12 Physio-Control, Inc. | MKJ |
| Nov 5, 2010 | K102757 | LIFENET SYSTEM Physio-Control, Inc. | MSX |
| Jan 12, 2010 | K093925 | LIFENET SYSTEM Physio-Control, Inc. | MSX |
| Mar 11, 2009 | K082937 | LIFEPAK 15 MONITOR/DEFIBRILLATOR Physio-Control, Inc. | MKJ |
| Jul 29, 2008 | K073089 | LIFEPAK 20E Physio-Control, Inc. | MKJ |
| Sep 3, 1999 | K991910 | LIFEPAK 12 BIPHASIC Physio-Control Corp. | MKJ |
| Sep 1, 1999 | K990338 | NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM Physio-Control Corp. | DXN |
| May 5, 1999 | K983393 | LIFEPAK 500 BIPHASIC Physio-Control Corp. | MKJ |
| Jan 9, 1998 | K973486 | LIFE PAK 12 Physio-Control Corp. | MKJ |
| Nov 6, 1997 | K962359 | LIFEPAK 300 Physio-Control Corp. | MKJ |
| Nov 4, 1996 | K955854 | LIFEPAK 500 Physio-Control Corp. | MKJ |
| Jan 11, 1996 | K953204 | PEDIATRIC QUIK-COMBO Physio-Control Corp. | MKJ |
| Dec 29, 1995 | K951593 | LIFEPAK 11 Physio-Control Corp. | DRO |
| Sep 26, 1995 | K945511 | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR Physio-Control Corp. | MPE |
| Feb 3, 1995 | K943301 | QUIK COMBO Physio-Control Corp. | DRX |
| Dec 7, 1994 | K941970 | FAST-PATCH Physio-Control Corp. | MKJ |
| Jun 8, 1994 | K925936 | LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR Physio-Control Corp. | MKJ |
| Mar 16, 1994 | K922315 | VITAL-COMBO(R) Physio-Control Corp. | LDD |
| Dec 16, 1993 | K935674 | LIFEPAK 9 DEFIBRILLATOR/MONITOR Physio-Control Corp. | LDD |
| May 18, 1993 | K931053 | LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER Physio-Control Corp. | LDD |
| Feb 21, 1992 | K912966 | PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG Physio-Control Corp. | LDD |
| Feb 14, 1992 | K912189 | LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 REC STATION Physio-Control Corp. | LOS |
| Sep 11, 1991 | K912599 | QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC Physio-Control Corp. | DRO |
| Jul 17, 1991 | K910144 | 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON Physio-Control Corp. | LDD |
| Feb 25, 1991 | K902288 | MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR Physio-Control Corp. | LDD |
| Dec 20, 1990 | K905510 | LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED Physio-Control Corp. | LDD |
| Oct 31, 1990 | K902478 | LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR Physio-Control Corp. | LDD |
| Feb 26, 1990 | K895379 | LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) Physio-Control Corp. | LDD |
| Oct 12, 1989 | K894540 | TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000 Physio-Control Corp. | DXH |
| Jun 20, 1989 | K892005 | SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9 Physio-Control Corp. | MKJ |
| Jun 5, 1989 | K892065 | LIFEPAK 250 DEFIBRILLATOR/MONITOR Physio-Control Corp. | MKJ |
| Feb 23, 1989 | K890079 | LIFEPAK 10 DEFIBRILLATOR/MONITOR Physio-Control Corp. | LDD |
| Dec 28, 1988 | K883617 | LIFEPAK 50 MONITOR/DEFIBRILLATOR Physio-Control Corp. | LDD |
| Sep 20, 1988 | K883121 | QUIK-PACE II ELECTRODES Physio-Control Corp. | DRO |
| Jul 27, 1988 | K881153 | LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR Physio-Control Corp. | LDD |
| Jun 9, 1988 | K881346 | LIFESTAT 1600 PRINTER Physio-Control Corp. | DSF |
| May 6, 1988 | K880554 | VSM(R) R2 PAPER CHART RECORDER Physio-Control Corp. | DSF |
| Dec 29, 1987 | K871751 | QUIK-PACE NONINVASIVE PACEMAKER Physio-Control Corp. | DRO |
| May 20, 1987 | K871224 | FAST-PATCH(TM) Physio-Control Corp. | LDD |
| Dec 11, 1986 | K864666 | MODIFIED LIFESTAT 200 Physio-Control Corp. | DXN |
| Dec 11, 1986 | K864665 | MODIFIED VSM 2 VITAL SIGNS MONITOR Physio-Control Corp. | DXN |
| Jun 9, 1986 | K853561 | LIFESTAT 100 Physio-Control Corp. | DXN |
Newest 50 of 94.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2026 | Physio-Control, Inc. 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, 9 Open, Classified |
MKJ | None listed |
| Mar 10, 2026 | Physio-Control, Inc. 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 Re Open, Classified |
MKJ | None listed |
| Sep 2, 2025 | Physio-Control, Inc. 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 cardiop Open, Classified |
MKJ | None listed |
| Sep 2, 2025 | Physio-Control, Inc. LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code:
320371500023 / 99425-000025 / 885074698953
320371500229 / 99425-000025 / 885074698953
331706400001 / 99425-000025 / 885074698953
LIFEPAK 1000: The Open, Classified |
MKJ | None listed |
| Sep 2, 2025 | Physio-Control, Inc. 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- Open, Classified |
MKJ | None listed |
| Feb 25, 2025 | Physio-Control, Inc. LIFEPAK 20e REF 99507-000001
The AED mode is to be used only on patients in cardiopulmonary arrest. Open, Classified |
MKJ | None listed |
| Feb 19, 2025 | Physio-Control, Inc. 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 Open, Classified |
MKJ | None listed |
| Feb 5, 2025 | Physio-Control, Inc. LIFEPAK 35 ECG cable REF 11111-000041 Open, Classified |
DSA | K240377 |
| Oct 25, 2024 | Physio-Control, Inc. 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 99577-0 Open, Classified |
MKJ | None listed |
| Oct 22, 2024 | Physio-Control, Inc. STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, s Open, Classified |
LDD | K182503 |
| Dec 15, 2023 | Physio-Control, Inc. AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 Open, Classified |
MKJ | None listed |
| Nov 14, 2023 | Physio-Control, Inc. LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 Open, Classified |
MKJ | None listed |
| Jan 13, 2022 | Physio-Control, Inc. HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak Terminated |
MKJ | None listed |
| Jan 14, 2021 | Physio-Control, Inc. 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 full Open, Classified |
MKJ | None listed |
| Apr 24, 2020 | Physio-Control, Inc. 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 Terminated |
MKJ | K022732 |
| Apr 24, 2020 | Physio-Control, Inc. 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 Terminated |
MKJ | K022732 |
| Apr 1, 2020 | Physio-Control, Inc. LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a pa Terminated |
MKJ | K012428 K052057 +2 |
| Dec 20, 2019 | Physio-Control, Inc. LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits Terminated |
MKJ | K142430 |
| Dec 20, 2019 | Physio-Control, Inc. LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad. Terminated |
MKJ | K142430 |
| Feb 26, 2019 | Physio-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 |
MKJ | K142430 |
| Feb 26, 2019 | Physio-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 |
MKJ | K142430 |
| Jan 11, 2018 | Physio-Control, Inc. LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273
Product Usage:
The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are author Terminated |
MKJ | K130454 |
| Dec 12, 2017 | Physio-Control, Inc. LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009
The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillato Terminated |
MKJ | K022732 |
| Dec 12, 2017 | Physio-Control, Inc. LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006
The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrill Terminated |
MKJ | K022732 |
| Mar 3, 2017 | Physio-Control, Inc. The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. Terminated |
MKJ | K122600 |
| Feb 11, 2017 | Physio-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 |
MKJ | K142430 |
| Jan 16, 2017 | Physio-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 |
MKJ | K142430 |
| Jan 16, 2017 | Physio-Control, Inc. LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option.
The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) an Terminated |
MKJ | K102972 |
| Jun 15, 2016 | Physio-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 |
MKJ | K142430 |
| May 25, 2016 | Physio-Control, Inc. LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable.
LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arr Terminated |
MKJ | K033275 |
| May 23, 2014 | Physio-Control, Inc. LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX
The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest. Terminated |
MKJ | K042404 |
| Jul 19, 2013 | Physio Control, Inc. The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) Terminated |
MKJ | K052057 |
| Apr 10, 2013 | Physio Control, Inc. The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006.
Automated external defibrillators. Terminated |
MKJ | K011144 |
| Nov 16, 2011 | Physio Control, Inc. The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings.
Affected Product Part Numbers: 3202487- Terminated |
LDD | K012274 |
| Jul 26, 2011 | Physio Control, Inc. The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System.
This software algorithm analyzes the patient's electrocardiographic (E Terminated |
MKJ | K052057 |
| Jun 22, 2011 | Physio Control, Inc. 12-lead ECG Cable Assembly contains the following cable and attachments:
Main Cable with Limb Leads: The main cable includes the proximal connector which attaches to the monitor and four incorporated Terminated |
MKJ | K973486 |
| Mar 18, 2011 | Physio Control, Inc. The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-000, U3202487-000, 3202488-015, and U3202488-000.
The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20 Terminated |
MKJ | K012274 K073089 |
| Mar 4, 2011 | Physio Control, Inc. The LIFEPAK12 Defibrillator/Monitor.
The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are aut Terminated |
MKJ | K010918 |
| Aug 28, 2010 | Physio Control, Inc. Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitors. Terminated |
LDD | K902288 |
| Aug 28, 2010 | Physio Control, Inc. External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor. Terminated |
LDD | K902288 |
| Jul 1, 2010 | Physio Control, Inc. LIFEPAK 20 defibrillator/monitor.
Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000. Terminated |
MKJ | K012274 |
Newest 50 of 72.