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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