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 |