FDA 510(k) Applications for Medical Device Product Code "DRS"
(Transducer, Blood-Pressure, Extravascular)

FDA 510(k) Number Applicant Device Name Decision Date
K904601 ADVANCE MEDICAL DESIGNS, INC. ADVANCE DISPOSABLE PRESSURE TRANSDUCER 12/17/1990
K884919 ADVANCED MEDICAL, INC. DISPOSABLE DOME STOCK #D-300 01/05/1989
K771668 AILTECH DISP. FLUID ISOLATOR & PRESS. RELIEF 09/14/1977
K831867 ALTO DEVELOPMENT CORP. PRESSURE MONITORING IV BOTTLE CAP 08/12/1983
K841811 AMERICAN BENTLEY BENTLEY-TRANTEC DISPOS. DOMES D-260- 09/09/1985
K840023 AMERICAN BENTLEY TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC 06/22/1984
K833792 AMERICAN BENTLEY TRANTECSILICONE QUARTZ DISP. TRANSD 02/10/1984
K872596 AMERICAN EDWARDS LABORATORIES TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 09/30/1987
K830210 AMERICAN PHARMASEAL DIV. AHSC DISPOSABLE PRESSURE TRANSDUCER 04/18/1983
K821894 AMERICAN PHARMASEAL DIV. AHSC DISPOSABLE TRANSDUCER DOMES & KITS 07/20/1982
K832907 AMERICAN PHARMASEAL DIV. AHSC INVASIVE MONITORING KITS 01/10/1984
K780128 APPLIED MEDICAL RESEARCH BLOOD PRESSURE MONITOR, ARTERIAL 01/31/1978
K780127 APPLIED MEDICAL RESEARCH DINAMAP MODEL 850 01/31/1978
K102033 B. BRAUN MELSUNGEN AG COMBITRANS MONITORING SETS AND ACCESSORIES 04/07/2011
K885296 BAXTER HEALTHCARE CORP. MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F 01/25/1989
K904777 BAXTER HEALTHCARE CORP. SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS 01/15/1991
K780477 BELL & HOWELL INSTRUMENTS PHYSIOLOGICAL PRESSURE TRANSDUCER 04/13/1978
K820046 BENTLEY LABORATORIES, INC. ANESTHESIOLOGY DEVICES 01/29/1982
K821416 BENTLEY LABORATORIES, INC. DISPOSABLE BLOOD PRESSURE TRANSDUCER 07/02/1982
K813053 BENTLEY LABORATORIES, INC. DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM 11/16/1981
K820342 BENTLEY LABORATORIES, INC. PHYSIOLOGICAL PRESSURE TRANSDUCER #900 03/04/1982
K801985 BIO-MED CORP. BIO-MED CORP. DISP. NON-STERILE TRANSDU 09/09/1980
K802069 BIO-MED CORP. DISP. TRANSDUCER DOMES TD200 & TD300 09/09/1980
K810735 BIO-MED CORP. DISPOSABLE, STERILE TRANSDUCER DOMES 05/08/1981
K823286 BIO-MED CORP. MODELS DPT 1000/DPT 1000NS 12/30/1982
K862344 BIO-TEK INSTRUMENTS, INC. GOULD XCALIBER 08/06/1986
K812530 BIOMEAL CORP. TRANSDUCER DOME 10/13/1981
K151040 BIOMETRIX LTD. Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer 09/04/2015
K070710 BIOSENSORS INTERNATIONAL-USA ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM 04/19/2007
K854505 BRENTWOOD INSTRUMENTS, INC. CARDIMAX FX-406U 02/04/1986
K884235 BURRON MEDICAL, INC. COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT 03/06/1990
K820186 C.R. BARD, INC. BARD CARDIOPULMONARY MONITORING LINES 02/12/1982
K830093 C.R. BARD, INC. USCI ELECTRONIC MANOMETER 01/28/1983
K161408 CENTURION MEDICAL PRODUCTS CORPORATION Compass Cast and MAP 11/22/2016
K921343 COBE CARDIOVASCULAR, INC. COBE PATIENT MONITORING PRODUCTS 01/05/1993
K810637 COBE LABORATORIES, INC. COBE DISPOSABLE PRESSURE TRANSDUCER 04/23/1981
K820579 CONMED CORP. FLEX-E1 ECG ELECTRODE 04/14/1982
K792073 DEL MAR AVIONICS MODEL 1979 BLOOD PRESSUROMETER R CHARTER 11/05/1979
K813267 DIO-MED CORP. DISPOSABLE DIAPHRAGM DOMES 12/14/1981
K152980 Edwards Lifesciences, LLC Flo Trac sensor, Volume View sensor 01/19/2016
K043065 EDWARDS LIFESCIENCES, LLC. VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P 01/26/2005
K120624 ELCAM MEDICAL A.C.A.L ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) 06/08/2012
K832897 ELECTROMEDICS, INC. MODEL TTPM TIME TEMP. PRESSURE MONITOR 03/22/1984
K812758 ELECTROMEDICS, INC. PHYSIOLOGICAL PRESSURE TRANSDUCER 10/20/1981
K761325 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. MODEL DA-53 PRESSURE GUAGE ISOLATOR 01/06/1977
K801136 GICS PHARMACEUTICALS D300 DOME 06/20/1980
K801138 GICS PHARMACEUTICALS MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN. 07/14/1980
K822507 GOULD, INC. DISPOSABLE TRANSDUCER & ACCESSORIES 09/14/1982
K851486 GOULD, INC. GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX 10/17/1985
K855145 GOULD, INC. MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR 02/26/1986
K811538 GOULD, INC. MODELS TA 1017 & 1017T GRITIFLO DISPOS 06/12/1981
K821450 GOULD, INC. PRESSURE TUBING-ADULT & PEDIATRIC 05/25/1982
K780797 GOULD, INC. TRANSDUCER, PRESSURE, OPTION, H-P, P23ID 06/13/1978
K800706 GRAPHIC CONTROLS CORP. MEDI-TRACE DISPOSABLE DOMES/MONITORING 04/16/1980
K820457 GRAPHIC CONTROLS CORP. MEDI-TRACE PHYSIOLOGICAL PRESSURE TRANS 03/12/1982
K843580 GRAPHIC CONTROLS CORP. MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO 05/28/1985
K800705 GRAPHIC CONTROLS CORP. MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO 04/16/1980
K811980 H.R. BIOMEDICAL, LTD. ELECTRONIC BLOOD PRESSURE TRANSDUCER MAN 07/28/1981
K843273 HEWLETT-PACKARD CO. DISPOS. PRESSURE KIT 1295K SERIES 06/11/1985
K860681 HEWLETT-PACKARD CO. DISPOSABLE FLUSH DEVICE 06/17/1986
K771361 HEWLETT-PACKARD CO. PHYSIOLOGICAL PRESSURE TRANSDUCER 1290A 08/04/1977
K840121 HEWLETT-PACKARD CO. PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C 05/16/1984
K841613 HEWLETT-PACKARD CO. PRESSURE TRANSDUCER DOME 1295C 10/24/1984
K851888 HONEYWELL, INC. APM DISPOS. BLOOD PRESSURE TRANSDUCER 08/06/1985
K052828 HOSPIRA, INC. DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) 02/17/2006
K061573 HOSPIRA, INC. TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT 09/19/2006
K881297 INSTROMEDIX, INC. BARO-GRAF 24 09/16/1988
K882118 IVY BIOMEDICAL SYSTEMS, INC. MODEL 700 PATIENT MONITOR 08/02/1988
K792020 LIFE MEDICAL SERVICES, INC. AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCER 12/07/1979
K820202 LINTON BIOMED CORP. CONTINUOUS FLUSH DEVICE/FDI 02/12/1982
K820201 LINTON BIOMED CORP. DISPOS. MONITORING SYS/LI ET AL 02/12/1982
K831348 LINTON BIOMED CORP. FLUID ADMIN. SET AFS-1C 05/27/1983
K921898 LORIC TECHNOLOGY "TAD" MODEL #9655 11/02/1992
K832657 MALLINCKRODT CRITICAL CARE DISPOSABLE MANIFOLD SET 11/07/1983
K900551 MATRIX MEDICA, INC. MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. 05/09/1990
K810009 MEDEX, INC. DISPOSABLE DIAPHRAGM DOME 02/19/1981
K820355 MEDEX, INC. DISPOSABLE DIAPHRAGM DOMES 03/04/1982
K790407 MEDEX, INC. MICROTEC BACTERIAL FILTER 05/16/1979
K883095 MEDEX, INC. MX860, REUSABLE PRESSURE TRANSDUCER 09/12/1988
K870301 MEDEX, INC. MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER 05/06/1987
K961404 MEDEX, INC. MX960 REUSABLE PRESSURE TRANSDUCER 06/27/1996
K951129 MEDEX, INC. NOVATRANS II 04/05/1995
K850898 MEDI-TRACE PRODUCTS DIVISION MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER 07/25/1985
K810661 MEDLINE INDUSTRIES, INC. "CATHDAMP" 03/27/1981
K123095 MEDLINE INDUSTRIES, INC. MEDLINE BLOOD PRESSURE TRANSDUCER 05/08/2013
K920977 MERIT MEDICAL SYSTEMS, INC. MERITRANS(TM) DISPOSABLE TRANSDUCER 12/11/1992
K133624 MIRADOR BIOMEDICAL COMPASS CT, COMPASS CT PORT 04/18/2014
K112203 MIRADOR BIOMEDICAL, INC. COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST 12/14/2011
K103715 MIRADOR BIOMEDICAL, INC. COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE 01/20/2011
K101518 MIRADOR BIOMEDICAL, INC. COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE 10/13/2010
K813549 NAMIC CONTINUOUS FLUSH DEVICE 01/12/1982
K951722 NAMIC PERCEPTOR COMPENSATOR MORSE MANIFOLD 03/25/1996
K813502 NARCO BIO-SYSTEMS NARCO TELECARE ISOFLO PRESSURE MONITOR 12/29/1981
K810431 NARCO BIO-SYSTEMS NARCO TLECARE MINIATURE PRESSURE DOME 03/11/1981
K812884 NARCO SCIENTIFIC NARCO TELECARE PRESSURE TRANSDUCER DOME 11/02/1981
K803096 NARCO SCIENTIFIC NARCO TELECARE TRANSDUCER DOME #700-4000 01/13/1981
K812883 NARCO SCIENTIFIC TELECARE ISOTEC PRESSURE TRANSDUCER DOME 11/02/1981
K840274 NIHON KOHDEN AMERICA, INC. CARDIOFAX ECG 6543 04/17/1984
K813266 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN ELECTROCARDIOGRAPH 01/29/1982
K902472 NORTH AMERICAN INSTRUMENT CORP. MORSE DT MANIFOLD 08/23/1990
K833271 NORTH AMERICAN INSTRUMENT CORP. NAMIC CONTINUOUS FLUSH DEVICE 12/01/1983
K910764 NORTH AMERICAN INSTRUMENT CORP. THE PERCEPTOR(TM) STAND ALONE TRANSDUCER 04/22/1991
K813137 NORTON PERFORMANCE PLASTICS CORP. CORREC TORR TM 12/02/1981
K831698 NORTON PERFORMANCE PLASTICS CORP. DISPOSABLE PRESSURE TRANSDUCER#14004195 08/11/1983
K820677 NORTON PERFORMANCE PLASTICS CORP. TOUCH FLUSH CONTINUOUS FAST/FLUSH 03/25/1982
K820676 NORTON PERFORMANCE PLASTICS CORP. TOUCH FLUSH W/Y TRANSDUCER CONNECTOR 03/25/1982
K871371 OMRON TATEISI ELECTRONICS CO. DIGITAL SPHYGMOMANOMETER 06/12/1987
K801239 PACIFIC DOMES, INC. STERILE, DISP DOME, INDIVID. PKG. 07/14/1980
K841968 PARKE-DAVIS CO. DESERET DISPOSABLE PRESSURE TRANSDUCER 08/06/1984
K781680 PHARMASEAL DIV., BAXTER HEALTHCARE CORP. MONITORING, PRESSURE KIT 10/06/1978
K823334 PSITRON PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630 03/24/1983
K930888 RALIN MEDICAL, INC. WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM 07/21/1993
K101189 REAVILLMED REAVILLMED PRESSURE MONITORING SYSTEM AND PICC 12/22/2010
K870356 REUNION MEDICAL CO. "TATCH-IT" 06/12/1987
K062342 SENTRA MEDICAL DEVICES, LLC TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT 09/25/2006
K091408 SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD DISPOSABLE PRESSURE TRANSDUCER 08/18/2009
K163172 SMITHS MEDICAL ASD, INC. HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit 05/24/2017
K172458 Smiths Medical ASD, Inc. HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit 11/09/2017
K801048 SORENSEN RESEARCH ACCUDYNAMIC 05/14/1980
K791636 SORENSEN RESEARCH ACCUNAMIC 10/04/1979
K831506 SORENSEN RESEARCH DISP. TRANSDUCER W/MONITORING KIT TRANS 08/12/1983
K813464 SORENSEN RESEARCH DISPOSABLE TRANSDUCER 01/07/1982
K833096 SORENSEN RESEARCH TRANSDUCER DOME DS106 11/03/1983
K833094 SORENSEN RESEARCH TRANSDUCER DOME SD104 11/03/1983
K833095 SORENSEN RESEARCH TRANSDUCER DOME SD105 11/03/1983
K873168 SPECTRAMED, INC. SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS 01/12/1988
K841960 STERILE DESIGN, INC. CARDIO METRICS INVASIVE PRESSURE MONIT 11/08/1985
K983372 SUNSCOPE INTL., INC. BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP 02/05/1999
K981747 SUNSCOPE INTL., INC. BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX 08/20/1998
K981745 SUNSCOPE INTL., INC. BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX 07/17/1998
K854596 TDK CORP. TDK ECG ELECTRODE MEL-08-09 & -11 05/07/1986
K802179 TELECTRONICS, INC. CARDIOSCOPE J200 11/12/1980
K852652 TELEMED DIV. OMNIGRAPH 4000(ELECTROCARDIOGRAPH) 11/19/1985
K092644 TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PRESSURE ISOLATOR 12/10/2009
K902453 THOMAS J. FOGARTY, M.D. OSCILLOMETRIC PULSE DETECTION DEVICE 08/23/1990
K851988 TRANSAMERICA DELAVAL, INC. ADMINISTRATION SET 08/16/1985
K853996 TRANSAMERICA DELAVAL, INC. DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE 05/07/1986
K851989 TRANSAMERICA DELAVAL, INC. DOME, DISPOSABLE, STERILE 08/19/1985
K833170 TRANSAMERICA DELAVAL, INC. FLUSH DEVICE 08/12/1984
K851987 TRANSAMERICA DELAVAL, INC. FLUSH DEVICE, AUTOMATIC 08/16/1985
K833171 TRANSAMERICA DELAVAL, INC. MONITORING KIT 09/06/1984
K820459 TRI-MED, INC. VIRAGARD/VIRASHIELD 06/16/1982
K842352 UTAH MEDICAL PRODUCTS, INC. PRESSURE MONITORING KIT 03/25/1985
K864090 UTAH MEDICAL PRODUCTS, INC. SHELF LIFE CHANGE OF STERILE DEVICES 03/20/1987
K841788 UTAH MEDICAL PRODUCTS, INC. UTAH DISPOSABLE PRESSURE TRANSDUCER 03/25/1985
K152472 ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. Disposable Pressure Transducer 10/31/2016


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