PHYSIO-CONTROL, INC.

FDA Device Registration & Listing · Redmond, WA, US · Registration 3015876

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015876
FEI Number
3015876
Entity Name
PHYSIO-CONTROL, INC.
City/State/Country
Redmond, WA, US
Establishment Address
11811 WILLOWS RD., N.E., Redmond, WA 98052, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P160026

All Registered Proprietary Names

QUIK-COMBO RTS pacing/defibrillation/ECG electrodes QUIK-COMBO pacing/defibrillation/ECG electrodes QUIK-COMBO RTS Pediatric pacing/defibrillation/ECG electrodes QUIK-COMBO pacing/defibrillation/ECG electrodes with REDI-PAK preconnected system LIFEPAK FLEX Battery Charger LIFEPAK Temperature Adapter Cable LIFEPAK® 35 AC Power Adapter LIFEPAK Printer Kit LIFEPAK Printer Cable LIFEPAK® Invasive Pressure Adapter Cable LIFEPAK EXPRESS LIFEPAK CR Plus Prep Kit LUCAS Power Supply with Cord LUCAS Car Cable 12V LUCAS 2 Battery LUCAS 2 LUCAS Battery Charger with Cord LUCAS PCI Back Plate LUCAS Back Plate Grip Tape LUCAS 3 LUCAS BATTERY, DARK GRAY LUCAS ANTI SLIP, SLIM BACK PLATE LIFEPAK 1000 LIFEPAK 20 LIFEPAK 15 LIFEPAK 35 LIFEPAK 20E

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2020-12-08
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2017-11-13
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2017-11-13
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2017-11-13
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2017-11-13
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-11-13
DQA Oximeter Cardiovascular Class 2 870.2700 2017-11-13
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2017-11-13
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) Cardiovascular Class 2 870.5550 2017-11-13
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-11-13
DRM Compressor, Cardiac, External Cardiovascular Class 2 870.5200 2018-02-14
MPD Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator Cardiovascular Class 2 870.5300 2024-05-16
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2024-05-16
DSF Recorder, Paper Chart Cardiovascular Class 1 870.2810 2024-10-23
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2024-05-16
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2018-01-04
PXD Prep Kit General Hospital Class 1 880.6250 2022-12-20
DRM Compressor, Cardiac, External Cardiovascular Class 2 870.5200 2017-12-13
DRM Compressor, Cardiac, External Cardiovascular Class 2 870.5200 2017-12-13
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2018-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003897776 BIOMIMETIC THERAPEUTICS,LLC FRANKLIN, TN, US
3040801290 Inari Medical, Costa Rica S.A. Grecia Alajuela, CR
2031049 TMJ Solutions, LLC San Buenaventura, CA, US
3016573902 Ortho-Space Ltd. Caesarea Haifa, IL
3010411911 POM Medical, LLC Moorpark, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04
K172904 Philips Medizin Systeme Boeblingen GmbH IntelliVue Capnography Extension, IntelliVue Microstream Extension 2017-12-26
K832250 Litton Medical Electronics SERVOMED BASIC BEDSIDE UNIT SMA 102- 1984-06-01
K801515 Abbott Medical Electronics Co. ABBY II PATIENT MONITOR OR VITAL SIGNS M 1980-07-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-06 Medtronic Emergency Response Systems, Inc. 3
Hard shell carry case for the LIFEPAK 500 AED.
Z-0005-06 Medtronic Emergency Response Systems, Inc. 3
Hard shell carry case for the LIFEPAK CR Plus.
Z-0003-2010 Philips Healthcare Inc. 3
HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0004-2017 Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria 3
Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Z-0011-2013 Philips Healthcare Inc. 3
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015876. Last updated year: 2026. Please use registration number 3015876 when referencing this establishment in official correspondence.
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