FDA 510(k) Applications for Medical Device Product Code "DXQ"
(Blood Pressure Cuff)

FDA 510(k) Number Applicant Device Name Decision Date
K800236 ABCO DEALERS, INC. ABCO MERCURIAL SPHYGMOMANOMETER 02/22/1980
K760655 ABCO DEALERS, INC. ANEROID SPHYGMOMANOMETER 10/05/1976
K792355 ABCO DEALERS, INC. ANEROID SPHYMOMANOMETER 12/05/1979
K821232 ABCO DEALERS, INC. ONE HAND ANEROID SPHYGMOMANOMETER 05/25/1982
K813323 ABCO DEALERS, INC. THIGH CUFF: X-LARGE CUFF 12/29/1981
K896788 ADVANCED MEDICAL INSTRUMENTS, INC. DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF 01/19/1990
K063863 ADVANTAGE MEDICAL CABLES, INC. ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER 03/20/2007
K801568 AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL SHIELD DISPOSABLE BLOOD PRESSURE CUFF 07/28/1980
K962655 AMERICAN DIAGNOSTIC CORP. ANEROID AND MERCURIAL SPHYGMOMANOMETERS 01/27/1997
K133117 ANDON HEALTH CO., LTD ANDON BLOOD PRESSURE CUFF 03/04/2014
K102825 APK TECHNOLOGY CO., LTD BLOOD PRESSURE CUFF 03/02/2011
K821095 ASSOCIATED MEDICAL DEVICES, INC. SPHYGURITE 06/10/1982
K881799 BIOMEDICAL DYNAMICS, INC. BLOOD PRESSURE CUFF 10/14/1988
K911213 BIOMEDICAL DYNAMICS, INC. CUFFABLE 08/07/1991
K820539 BIOMET, INC. RELIEVED REINFORCED CUP 03/15/1982
K812946 BIOMET, INC. TRONZO HIP 11/06/1981
K952825 BOWEN MEDICAL SERVICES, INC. CUFF GUARD 09/15/1995
K902132 BUFFALO MEDICAL SPECIALTIES MFG., INC. CUFF, BLOOD PRESSURE 06/29/1990
K023356 CARD GUARD SCIENTIFIC SURVIVAL, LTD. KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR 01/16/2003
K082542 CARDICARE COMPANY, LTD. ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A 09/17/2008
K090014 CAREMATE MEDICAL DEVICE CO., LTD CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE 04/09/2009
K102792 CAREMATE MEDICAL DEVICE CO., LTD DISPOSABLE BLOOD PRESSURE CUF 01/26/2011
K000512 CAS MEDICAL SYSTEMS, INC. OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 09/26/2000
K031416 CLEAR MEDICAL, INC. CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF 07/15/2003
K882121 CONCEPT, INC. C-FLO SUCTION TUBE 06/20/1988
K792108 CONPHAR, INC. CONPHAR BLOOD PRESSURE CUFFS 12/04/1979
K801186 CONPHAR, INC. CONPHAR DELUXE ANEROID SPHYGMOMANOMETER 06/09/1980
K801188 CONPHAR, INC. CONPHAR DESK TOP MERCURY SPHYGMOMAN 06/09/1980
K813302 CONPHAR, INC. CONPHAR PALM ANEROID SPHYGMOMANOMETER 01/22/1982
K801182 CONPHAR, INC. CONPHAR WALL MODEL MERCURY SPHYGMOMAN. 06/04/1980
K813303 CONPHAR, INC. CONPHAR, WALL ANEROID SPHYGMOMANOMETER 01/22/1982
K790810 CREST MEDICAL EQUIPMENT DISPOSA-CUF 05/25/1979
K972899 CYPRESS MEDICAL PRODUCTS, LTD. CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER 07/07/1998
K041689 D. E. HOKANSON, INC. POLYURETHANE BLOOD PRESSURE CUFFS 08/06/2004
K781671 DAVID COTT CO. BLOOD PRESSURE CUFF COVER 11/16/1978
K823843 DEPUY, INC. FREEMAN ACETABULAR CUP 03/29/1983
K852193 DEPUY, INC. POROCOAT SCHATZKER II ACETABULUM 07/30/1985
K953952 DEROYAL INDUSTRIES, INC. DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF 09/28/1995
K991525 DEROYAL INDUSTRIES, INC. DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF 07/20/1999
K874233 DEVCOM, INC. BLOOD PRESSURE SLEEVE W/TUBING 03/22/1988
K090664 DEVON MEDICAL INC. DEVON ACCUBP CUFF 03/23/2009
K831479 DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS METAL-BACKED ACETABULAR CUP 06/15/1983
K092999 DRAEGER MEDICAL AG & CO. KG NBP CUFF 11/24/2009
K103637 ERKA KALLMEYER MEDIZINTECHNIK GMBH ERKA. PERFECT-ANEROID 06/08/2011
K031195 ETHOX CORP. CUF-COVER (TM) 10/10/2003
K844988 ETHOX CORP. ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. 04/04/1985
K040286 ETHOX CORP. ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS 03/15/2004
K883977 ETHOX CORP. SURGI-CUF STERILE/NON-STERILE DISPOSABLE 02/10/1989
K061962 ETHOX INTERNATIONAL SURGI-CUF REUSABLE, RS SERIES 07/25/2006
K760157 EYVIRCO SPHYGMOMANOMETER 07/19/1976
K801099 FRONTIER PRODUCTS UNICUF, BLOOD PRESSURE CUFF 05/30/1980
K831001 FRONTIER PRODUCTS UNICUFF-BLOOD PRESSURE CUFF 07/28/1983
K022482 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES SENSA-CUFF, MODELS INFANT, CHILD, ADULT 08/13/2002
K123996 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF 04/09/2013
K120125 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF 10/03/2012
K953466 GENERIC MEDICAL, INC. GENERICUFF 09/15/1995
K012553 GLOBALSHOP, INC. GSIBP BLOOD PRESSURE CUFF 08/17/2001
K010686 GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD. KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C 03/21/2001
K043444 GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD. MULTIPLE, MODEL KTJ-50 02/22/2005
K122259 HANGZHOU RELI-ON CO., LTD BLOOD PRESSURE MONITOR WITH STETHOSCOPE 09/24/2012
K101892 HEINE OPTOTECHNIK GMBH & CO. KG. HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- 08/27/2010
K905147 HEWLETT-PACKARD CO. ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS 12/27/1990
K901252 HEWLETT-PACKARD CO. HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS 07/31/1990
K905101 HEWLETT-PACKARD CO. NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF 12/20/1990
K092245 HONSUN (NANTONG) CO., LTD ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 10/28/2009
K830097 HOWMEDICA CORP. AUFRANC-TURNER ATS METAL BACKED ACETABU 01/28/1983
K851565 HOWMEDICA CORP. HOMEDICA CEMENTED ACETABULAR COMPONENT 6262 07/19/1985
K852964 HOWMEDICA CORP. P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION 07/29/1985
K152006 ICU MEDICAL INC. Cogent Hemodynamic Monitoring System 05/05/2016
K991545 INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK 01/19/2000
K854752 INTL. MEDICATION SYSTEMS, LTD. THE CALIFORNIA SPLINT 12/17/1985
K810838 INVIVO RESEARCH LABS, INC. NEONATAL BLOOD PRESSURE CUFF 04/03/1981
K151246 Jiaxing Zhongfa Medical Products Co., Ltd. Aneroid Sphygmomanometer 06/30/2015
K974080 JOHNSON & JOHNSON MEDICAL, INC. CRITIKON SOFT BLOOD PRESSURE CUFF 05/18/1998
K874939 KIRSCHNER MEDICAL CORP. SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED 02/02/1988
K143332 KOVEN TECHNOLOGY, INC. Fast Sphyg by Koven 04/14/2015
K896986 LATEX MEDICAL DEVICES, INC. BLOOD PRESSURE CUFF 03/06/1990
K130942 LEGACY MEDICAL, INC. LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF 10/17/2013
K921997 LORIN MEDICAL, INC. CUFF-M 07/23/1992
K945035 M-PACT WORLDWIDE, LLC. OCL CONTOUR 11/15/1994
K780715 MARS METAL CO., LTD. ANEROID TYPE BLOOD PRESSURE KIT 07/17/1978
K810008 MARTIN'S MAINE EXCHANGE ALP-KII 01/16/1981
K032568 MED TEXTILE, LLC BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193 04/29/2004
K931087 MED-CON, INC. CLEANCUFF(TM) 05/27/1993
K942488 MED-CON, INC. MEDCUFF 08/23/1994
K800767 MEDASONICS, INC. MOD. MCI 17 MANUAL CUFF INFLATOR 04/24/1980
K831393 MEDASONICS, INC. VASCULAB BLOOD PRESSURE CUFF 06/16/1983
K161035 MEDLINE INDUSTRIES, INC. Medline Singe Patient Use Blood Pressure Cuff 06/13/2016
K071244 MEDLINE INDUSTRIES, INC. MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF 03/05/2008
K854813 MEDNOVA CORP. MEDNOVA BLOOD PRESSURE CUFF 06/20/1986
K963987 N.A. BRAGGS MEDICAL, INC. CAMOUFLAGE CUFF SAVERS 07/23/1997
K012194 NIHON SEIMITSU SOKKI CO., LTD. BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110 07/20/2001
K173044 Ningbo Albert Novosino Co.,Ltd. Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff 11/20/2017
K153251 NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD. Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff 04/14/2016
K811634 NORTH AMERICAN PHILIPS CORP. NORELCO ANEROID BLOOD PRESSURE METER 06/30/1981
K173197 Orantech Inc. Reusable NIBP Cuff 08/21/2018
K910903 PA MEDICAL CORP. INFLATE-A-CUFF #7014 05/08/1991
K002360 PARTS PORT, LTD. CLOUD CUFF 09/26/2000
K951039 PEDIA PALS, INC. BLOOD PRESSURE CUFF 1 10/31/1995
K951040 PEDIA PALS, INC. BLOOD PRESSURE CUFF 2 10/31/1995
K951041 PEDIA PALS, INC. BLOOD PRESSURE CUFF 3 10/31/1995
K152363 PHILIPS MEDICAL SYSTEMS Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M 10/27/2015
K854023 PHILIPS PARK NORELCO ELECTRONIC DIGITAL BP METER HC3501 03/26/1986
K141998 PINGHU SAMA MEDICAL PACKING CO., LTD. SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS 09/19/2014
K150227 PINHU SAMA MEDICAL PACKING CO., LTD. Disposable Blood Pressure Cuff Guard 04/02/2015
K936313 PREVENTION SCIENCES CMS-90 BLOOD PRESSURE MEASUREMENT ASSISTANT 07/20/1994
K964648 PROTECT ALL, INC. PROTECT ALL BLOOD PRESSURE CUFF COVER 02/18/1997
K012444 PT. SUGIH INSTRUMENDO ABADI ABN ANEROID SPHYGMOMANOMETER 08/16/2001
K930604 PYMAH CORP. BALANCED(TM) NYLON BLADDER 04/30/1993
K884421 PYMAH CORP. PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT 01/13/1989
K903379 PYMAH CORP. PYMAH PRE-GAGED BALANCED TEMPA-KUFF 10/19/1990
K934180 PYMAH CORP. SLIMLINE 3000 11/24/1993
K925744 PYMAH CORP. TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF 07/30/1993
K053006 ROSSMAX INTERNATIONL LTD. ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II 02/03/2006
K972301 RUDOLF RIESTER GMBH & CO. KG BIG BEN SQUARE, BIG BEN ROUND 09/17/1997
K002955 RUDOLF RIESTER GMBH & CO. KG EMPIRE N BLOOD PRESSURE MANOMETERS 12/21/2000
K942777 RUDOLF RIESTER GMBH & CO. KG MINIMUS II; MINIMUS II COLOR; BABYPHON 07/27/1994
K972379 RUDOLF RIESTER GMBH & CO. KG PRECISA N 09/24/1997
K925297 RUDOLF RIESTER GMBH & CO. KG RI-MED 01/14/1994
K972377 RUDOLF RIESTER GMBH & CO. KG RI-MEGA 09/24/1997
K002954 RUDOLF RIESTER GMBH & CO. KG RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS 12/21/2000
K972378 RUDOLF RIESTER GMBH & CO. KG SANAPHON N 09/24/1997
K140874 SHANGHAI GOAHUI RUBBER AND PLASTIC COMPANY GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF 09/02/2014
K180335 Shanghai Hulu Devices Co., Ltd Accutension Smartphone Auscultatory Blood 03/08/2018
K051021 SHANGHAI LORD INTERNATIONAL TRADE CO., LTD. ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A 06/20/2005
K950778 SHANGHAI MEDIFRIEND MEDICAL PRODUCTS CO., LTD. MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER 03/14/1995
K173869 Shenzhen Med-link Electronics Tech Co., Ltd Med-link Reusable Blood Pressure Cuff 08/02/2018
K160530 SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff 11/28/2016
K151810 SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. Bpump Blood Pressure Cuff 12/17/2015
K152465 Shenzhen Vistar Medical Supplies Co., Ltd. Disposable Blood Pressure Cuff 10/29/2015
K152468 Shenzhen Vistar Medical Supplies Co., Ltd. Reusable Blood Pressure Cuff 10/29/2015
K101972 SOLARIS MEDICAL TECHNOLOGY, INC. SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS 07/22/2010
K152801 STATCORP MEDICAL ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT 10/27/2015
K940214 STATCORP, INC. STATCORP INC. DISPOSABLE BLOOD PRESSURE CUFF 02/22/1994
K954282 STATCORP, INC. ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG 02/06/1996
K925352 STERIDYNE CORP. CLEAN CUFF BLOOD PRESSURE CUFF LINER 01/12/1993
K051904 SUNTECH MEDICAL, INC. ALL PURPOSE CUFF, MODEL 222APC 09/09/2005
K080854 SUNTECH MEDICAL, INC. DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 10/20/2008
K141392 SUZHOU JJ METER CO., LTD. SPHYGMOMANOMETER 07/02/2014
K143728 SUZHOU MINHUA MEDICAL APPARATUS Minhua Disposable Blood Pressure Cuff 05/15/2015
K171889 Suzhou Minhua Medical Apparatus Supplies Co., LTD Reusable Blood Pressure Cuff 12/19/2017
K771501 SWARTZ MEDICAL EQUIPMENT ANEROID SPHYGMOMETER 08/30/1977
K942259 TECHNICUFF CORP. TECHNICUFF 09/06/1994
K912007 TECNADYNE SCIENTIFIC, INC. BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF 07/22/1991
K092604 TRIMLINE MEDICAL PRODUCTS CORP. LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX 10/21/2009
K080189 TRIMLINE MEDICAL PRODUCTS CORP. TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX 08/15/2008
K062238 TYTAN MEDICAL CORP. TYTAN BLOOD PRESSURE CUFF 09/21/2006
K112544 UNIMED MEDICAL SUPPLIES INC. UNIMED BLOOD PRESSURE CUFF 11/22/2011
K120364 UNIMED MEDICAL SUPPLIES INC. UNIMED DISPOSABLE BLOOD PRESSURE CUFF 05/04/2012
K872144 VESTRA-SUBCO, INC. MODIFIED DIGITAL BLOOD PRESSURE/PULSE METER 07/29/1987
K912638 VITAL SIGNS, INC. BLOOD PRESSURE CUFFS 07/25/1991
K994044 VITAL SIGNS, INC. CLEEN-ABLE 02/25/2000
K990412 VITAL SIGNS, INC. CUFF-ABLE PLUS 09/01/1999
K003415 WANG & LI, INC. ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE 01/03/2001
K791875 WARNER-LAMBERT CO. PARKE-DAVIS TOTAL HIP PROSTHESIS 10/04/1979
K122058 WELCH ALLYN, INC. FLEXIPORT ECOCUFF 11/05/2012
K940493 WELCH ALLYN, INC. HAND ANEROID SPHYGMOMANOMETER 07/01/1994
K012455 WELCH ALLYN, INC. WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM 08/17/2001
K070060 WELCH ALLYN, INC. WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) 12/18/2007
K043286 WENZHOU BOKANG INSTRUMENT CO.,LTD ANEROID SPHYGMOMANOMETER, MODEL BK2002 01/13/2005
K173246 Wenzhou Bokang Instruments Co., Ltd ANEROID SPHYGMOMANOMETER 05/30/2018
K081951 WENZHOU KINDCARE IMPORT & EXPORT CO., LTD ANEROID SPHYGMOMANOMETER, MODEL KT-A01 08/15/2008
K060871 WENZHOU LONGWAN MEDICAL INSTRUMENT COMPANY AS101, BLOOD PRESSURE CUFF 06/09/2006
K102823 WUXI MEDICAL INSTRUMENT FACTORY DISPOSABLE BLOOD PRESSURE CUFF 01/07/2011
K151290 XUZHOU MAICUFF TECHNOLOGY CO.,LTD. Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff 06/30/2015
K051539 YA HORNG ELECTRONIC CO., LTD. TRICOT BLOOD PRESSURE CUFF 08/05/2005
K901506 YAMASU CO. LTD. ANEROID SPHYGMOMANOMETER, DOCTOR TYPE 05/09/1990
K080366 ZEFON INTL. DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES 06/09/2008
K082630 ZEFON INTL. VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES 12/19/2008


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