Product Code: DXQ FDA class 2 21 CFR 870.1120

Blood Pressure Cuff

Cardiovascular

The Blood Pressure Cuff is a cardiovascular device consisting of an inflatable bladder housed within an elastic sleeve, used together with a pressure gauge to determine a subject's arterial blood pressure. It is classified as FDA Class 2, indicating moderate risk, and must receive 510(k) clearance before marketing. The product code is DXQ and the applicable regulation is 21 CFR 870.1120, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

193

FEI Numbers

175

Registration Numbers

175

Unique Applicants

139

Years Active

Basic Information

Product Code: DXQ
Device Class: FDA class 2
Regulation Number: 870.1120
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 193 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242623	Disposable Blood Pressure cuff; Reusable Blood Pressure cuff	Oct 31, 2024	Substantially Equivalent	Shenzhen Medke Technology Co., Ltd.
K240165	Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer	Mar 20, 2024	Substantially Equivalent	Wenzhou Longwan Medical Device Factory
K233276	Reusable Blood Pressure Cuff	Dec 21, 2023	Substantially Equivalent	Suzhou Minhua Medical Apparatus Supplies Co., LTD
K232772	Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)	Nov 29, 2023	Substantially Equivalent	Shenzhen Plinma Technology Co. Ltd.
K231961	NIBPCuff	Aug 30, 2023	Substantially Equivalent	Shenzhen SINO-K Medical Technology Co.,Ltd
K230859	Aneroid Sphygmomanometer	Jun 28, 2023	Substantially Equivalent	Wenzhou Kangshun Medical Devices Co.,Ltd
K230145	ONE-CUF	Mar 14, 2023	Substantially Equivalent	GE Medical Systems Information Technologies, Inc.
K222652	Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer	Nov 28, 2022	Substantially Equivalent	Cardicare Company, Ltd.
K222420	Disposable Blood Pressure Cuff	Nov 21, 2022	Substantially Equivalent	Wenzhou Xikang Medical Instruments Co., Ltd.
K221857	Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201	Oct 13, 2022	Substantially Equivalent	Zhejiang LuDe Technology Development Co., Ltd.
K212416	WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203	May 18, 2022	Substantially Equivalent	Wenzhou Xikang Medical Instruments Co., Ltd
K211084	Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope	Oct 19, 2021	Substantially Equivalent	Shanghai Caremate Medical Device Co. Ltd
K211747	Reusable NIBP Cuff	Sep 23, 2021	Substantially Equivalent	Shenzhen Coreray Technology Co., Ltd.
K203620	Aneroid Sphygmomanometer	Mar 23, 2021	Substantially Equivalent	Wuxi Exanovo Medical Instrument Co., Ltd.
K203652	Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D	Jan 06, 2021	Substantially Equivalent	JKH USA, LLC
K202543	OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip	Sep 28, 2020	Substantially Equivalent	Volcano Corporation
K193259	Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer	Jul 02, 2020	Substantially Equivalent	Little Doctor Electronic (Nantong)Co.,Ltd
K192500	Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer	Apr 06, 2020	Substantially Equivalent	Honsun(Nantong)Co.,Ltd
K193629	Disposable NIBP Cuff	Mar 25, 2020	Substantially Equivalent	Shenzhen Changke Connect Electronics Co., Ltd.
K191253	Reusable NIBP Cuff	Sep 17, 2019	Substantially Equivalent	Shenzhen Changke Connect Electronics Co., Ltd.
K191209	Aneroid Type Blood Pressure Kit	Jun 18, 2019	Substantially Equivalent	Dongguan Mars Medical Products Co., Ltd
K190902	RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope	May 22, 2019	Substantially Equivalent	Wenzhou Renhua Instruments Co., Ltd
K182433	Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff	Dec 17, 2018	Substantially Equivalent	Shenzhen Caremed Medical Technology Co., Ltd.
K173197	Reusable NIBP Cuff	Aug 21, 2018	Substantially Equivalent	Orantech Inc.
K173869	Med-link Reusable Blood Pressure Cuff	Aug 02, 2018	Substantially Equivalent	Shenzhen Med-link Electronics Tech Co., Ltd
K173246	ANEROID SPHYGMOMANOMETER	May 30, 2018	Substantially Equivalent	Wenzhou Bokang Instruments Co., Ltd
K180335	Accutension Smartphone Auscultatory Blood	Mar 08, 2018	Substantially Equivalent	Shanghai Hulu Devices Co., Ltd
K171889	Reusable Blood Pressure Cuff	Dec 19, 2017	Substantially Equivalent	Suzhou Minhua Medical Apparatus Supplies Co., LTD
K173044	Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff	Nov 20, 2017	Substantially Equivalent	Ningbo Albert Novosino Co.,Ltd.
K160530	Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff	Nov 28, 2016	Substantially Equivalent	SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
K161035	Medline Singe Patient Use Blood Pressure Cuff	Jun 13, 2016	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K152006	Cogent Hemodynamic Monitoring System	May 05, 2016	Substantially Equivalent	ICU MEDICAL INC.
K153251	Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff	Apr 14, 2016	Substantially Equivalent	NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD.
K151810	Bpump Blood Pressure Cuff	Dec 17, 2015	Substantially Equivalent	SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
K152468	Reusable Blood Pressure Cuff	Oct 29, 2015	Substantially Equivalent	Shenzhen Vistar Medical Supplies Co., Ltd.
K152465	Disposable Blood Pressure Cuff	Oct 29, 2015	Substantially Equivalent	Shenzhen Vistar Medical Supplies Co., Ltd.
K152801	ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT	Oct 27, 2015	Substantially Equivalent	STATCORP MEDICAL
K152363	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	Oct 27, 2015	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K151290	Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff	Jun 30, 2015	Substantially Equivalent	XUZHOU MAICUFF TECHNOLOGY CO.,LTD.
K151246	Aneroid Sphygmomanometer	Jun 30, 2015	Substantially Equivalent	Jiaxing Zhongfa Medical Products Co., Ltd.
K143728	Minhua Disposable Blood Pressure Cuff	May 15, 2015	Substantially Equivalent	SUZHOU MINHUA MEDICAL APPARATUS
K143332	Fast Sphyg by Koven	Apr 14, 2015	Substantially Equivalent	KOVEN TECHNOLOGY, INC.
K150227	Disposable Blood Pressure Cuff Guard	Apr 02, 2015	Substantially Equivalent	PINHU SAMA MEDICAL PACKING CO., LTD.
K141998	SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS	Sep 19, 2014	Substantially Equivalent	PINGHU SAMA MEDICAL PACKING CO., LTD.
K140874	GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF	Sep 02, 2014	Substantially Equivalent	SHANGHAI GOAHUI RUBBER AND PLASTIC COMPANY
K141392	SPHYGMOMANOMETER	Jul 02, 2014	Substantially Equivalent	SUZHOU JJ METER CO., LTD.
K133117	ANDON BLOOD PRESSURE CUFF	Mar 04, 2014	Substantially Equivalent	ANDON HEALTH CO., LTD
K130942	LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF	Oct 17, 2013	Substantially Equivalent	LEGACY MEDICAL, INC.
K123996	RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF	Apr 09, 2013	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
K122058	FLEXIPORT ECOCUFF	Nov 05, 2012	Substantially Equivalent	WELCH ALLYN, INC.
K120125	SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF	Oct 03, 2012	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
K122259	BLOOD PRESSURE MONITOR WITH STETHOSCOPE	Sep 24, 2012	Substantially Equivalent	HANGZHOU RELI-ON CO., LTD
K120364	UNIMED DISPOSABLE BLOOD PRESSURE CUFF	May 04, 2012	Substantially Equivalent	UNIMED MEDICAL SUPPLIES INC.
K112544	UNIMED BLOOD PRESSURE CUFF	Nov 22, 2011	Substantially Equivalent	UNIMED MEDICAL SUPPLIES INC.
K103637	ERKA. PERFECT-ANEROID	Jun 08, 2011	Substantially Equivalent	ERKA KALLMEYER MEDIZINTECHNIK GMBH
K102825	BLOOD PRESSURE CUFF	Mar 02, 2011	Substantially Equivalent	APK TECHNOLOGY CO., LTD
K102792	DISPOSABLE BLOOD PRESSURE CUF	Jan 26, 2011	Substantially Equivalent	CAREMATE MEDICAL DEVICE CO., LTD
K102823	DISPOSABLE BLOOD PRESSURE CUFF	Jan 07, 2011	Substantially Equivalent	WUXI MEDICAL INSTRUMENT FACTORY
K101892	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-	Aug 27, 2010	Substantially Equivalent	HEINE OPTOTECHNIK GMBH & CO. KG.
K101972	SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS	Jul 22, 2010	Substantially Equivalent	SOLARIS MEDICAL TECHNOLOGY, INC.
K092999	NBP CUFF	Nov 24, 2009	Substantially Equivalent	DRAEGER MEDICAL AG & CO. KG
K092245	ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100	Oct 28, 2009	Substantially Equivalent	HONSUN (NANTONG) CO., LTD
K092604	LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX	Oct 21, 2009	Substantially Equivalent	TRIMLINE MEDICAL PRODUCTS CORP.
K090014	CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE	Apr 09, 2009	Substantially Equivalent	CAREMATE MEDICAL DEVICE CO., LTD
K090664	DEVON ACCUBP CUFF	Mar 23, 2009	Substantially Equivalent	DEVON MEDICAL INC.
K082630	VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES	Dec 19, 2008	Substantially Equivalent	ZEFON INTL.
K080854	DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100	Oct 20, 2008	Substantially Equivalent	SUNTECH MEDICAL, INC.
K082542	ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A	Sep 17, 2008	Substantially Equivalent	CARDICARE COMPANY, LTD.
K081951	ANEROID SPHYGMOMANOMETER, MODEL KT-A01	Aug 15, 2008	Substantially Equivalent	WENZHOU KINDCARE IMPORT & EXPORT CO., LTD
K080189	TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX	Aug 15, 2008	Substantially Equivalent	TRIMLINE MEDICAL PRODUCTS CORP.
K080366	DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES	Jun 09, 2008	Substantially Equivalent	ZEFON INTL.
K071244	MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF	Mar 05, 2008	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K070060	WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)	Dec 18, 2007	Substantially Equivalent	WELCH ALLYN, INC.
K063863	ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER	Mar 20, 2007	Substantially Equivalent	ADVANTAGE MEDICAL CABLES, INC.
K062238	TYTAN BLOOD PRESSURE CUFF	Sep 21, 2006	Substantially Equivalent	TYTAN MEDICAL CORP.
K061962	SURGI-CUF REUSABLE, RS SERIES	Jul 25, 2006	Substantially Equivalent	ETHOX INTERNATIONAL
K060871	AS101, BLOOD PRESSURE CUFF	Jun 09, 2006	Substantially Equivalent	WENZHOU LONGWAN MEDICAL INSTRUMENT COMPANY
K053006	ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II	Feb 03, 2006	Substantially Equivalent	ROSSMAX INTERNATIONL LTD.
K051904	ALL PURPOSE CUFF, MODEL 222APC	Sep 09, 2005	Substantially Equivalent	SUNTECH MEDICAL, INC.
K051539	TRICOT BLOOD PRESSURE CUFF	Aug 05, 2005	Substantially Equivalent	YA HORNG ELECTRONIC CO., LTD.
K051021	ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A	Jun 20, 2005	Substantially Equivalent	SHANGHAI LORD INTERNATIONAL TRADE CO., LTD.
K043444	MULTIPLE, MODEL KTJ-50	Feb 22, 2005	Substantially Equivalent	GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.
K043286	ANEROID SPHYGMOMANOMETER, MODEL BK2002	Jan 13, 2005	Substantially Equivalent	WENZHOU BOKANG INSTRUMENT CO.,LTD
K041689	POLYURETHANE BLOOD PRESSURE CUFFS	Aug 06, 2004	Substantially Equivalent	D. E. HOKANSON, INC.
K032568	BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193	Apr 29, 2004	Substantially Equivalent	MED TEXTILE, LLC
K040286	ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS	Mar 15, 2004	Substantially Equivalent	ETHOX CORP.
K031195	CUF-COVER (TM)	Oct 10, 2003	Substantially Equivalent	ETHOX CORP.
K031416	CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF	Jul 15, 2003	Substantially Equivalent	CLEAR MEDICAL, INC.
K023356	KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR	Jan 16, 2003	Substantially Equivalent	CARD GUARD SCIENTIFIC SURVIVAL, LTD.
K022482	SENSA-CUFF, MODELS INFANT, CHILD, ADULT	Aug 13, 2002	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K012553	GSIBP BLOOD PRESSURE CUFF	Aug 17, 2001	Substantially Equivalent	GLOBALSHOP, INC.
K012455	WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM	Aug 17, 2001	Substantially Equivalent	WELCH ALLYN, INC.
K012444	ABN ANEROID SPHYGMOMANOMETER	Aug 16, 2001	Substantially Equivalent	PT. SUGIH INSTRUMENDO ABADI
K012194	BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110	Jul 20, 2001	Substantially Equivalent	NIHON SEIMITSU SOKKI CO., LTD.
K010686	KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C	Mar 21, 2001	Substantially Equivalent	GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.
K003415	ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE	Jan 03, 2001	Substantially Equivalent	WANG & LI, INC.
K002955	EMPIRE N BLOOD PRESSURE MANOMETERS	Dec 21, 2000	Substantially Equivalent	RUDOLF RIESTER GMBH & CO. KG
K002954	RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS	Dec 21, 2000	Substantially Equivalent	RUDOLF RIESTER GMBH & CO. KG
K002360	CLOUD CUFF	Sep 26, 2000	Substantially Equivalent	PARTS PORT, LTD.
K000512	OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010	Sep 26, 2000	Substantially Equivalent	CAS MEDICAL SYSTEMS, INC.
K994044	CLEEN-ABLE	Feb 25, 2000	Substantially Equivalent	VITAL SIGNS, INC.
K991545	WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK	Jan 19, 2000	Substantially Equivalent	INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI
K990412	CUFF-ABLE PLUS	Sep 01, 1999	Substantially Equivalent	VITAL SIGNS, INC.
K991525	DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF	Jul 20, 1999	Substantially Equivalent	DEROYAL INDUSTRIES, INC.
K972899	CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER	Jul 07, 1998	Substantially Equivalent	CYPRESS MEDICAL PRODUCTS, LTD.
K974080	CRITIKON SOFT BLOOD PRESSURE CUFF	May 18, 1998	Substantially Equivalent	JOHNSON & JOHNSON MEDICAL, INC.
K972379	PRECISA N	Sep 24, 1997	Substantially Equivalent	RUDOLF RIESTER GMBH & CO. KG
K972378	SANAPHON N	Sep 24, 1997	Substantially Equivalent	RUDOLF RIESTER GMBH & CO. KG
K972377	RI-MEGA	Sep 24, 1997	Substantially Equivalent	RUDOLF RIESTER GMBH & CO. KG
K972301	BIG BEN SQUARE, BIG BEN ROUND	Sep 17, 1997	Substantially Equivalent	RUDOLF RIESTER GMBH & CO. KG
K963987	CAMOUFLAGE CUFF SAVERS	Jul 23, 1997	Substantially Equivalent	N.A. BRAGGS MEDICAL, INC.
K964648	PROTECT ALL BLOOD PRESSURE CUFF COVER	Feb 18, 1997	Substantially Equivalent	PROTECT ALL, INC.
K962655	ANEROID AND MERCURIAL SPHYGMOMANOMETERS	Jan 27, 1997	Substantially Equivalent	AMERICAN DIAGNOSTIC CORP.
K954282	ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG	Feb 06, 1996	Substantially Equivalent	STATCORP, INC.
K951041	BLOOD PRESSURE CUFF 3	Oct 31, 1995	Substantially Equivalent	PEDIA PALS, INC.
K951040	BLOOD PRESSURE CUFF 2	Oct 31, 1995	Substantially Equivalent	PEDIA PALS, INC.
K951039	BLOOD PRESSURE CUFF 1	Oct 31, 1995	Substantially Equivalent	PEDIA PALS, INC.
K953952	DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF	Sep 28, 1995	Substantially Equivalent	DEROYAL INDUSTRIES, INC.
K953466	GENERICUFF	Sep 15, 1995	Substantially Equivalent	GENERIC MEDICAL, INC.
K952825	CUFF GUARD	Sep 15, 1995	Substantially Equivalent	BOWEN MEDICAL SERVICES, INC.
K950778	MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER	Mar 14, 1995	Substantially Equivalent	SHANGHAI MEDIFRIEND MEDICAL PRODUCTS CO., LTD.
K945035	OCL CONTOUR	Nov 15, 1994	Substantially Equivalent	M-PACT WORLDWIDE, LLC.
K942259	TECHNICUFF	Sep 06, 1994	Substantially Equivalent	TECHNICUFF CORP.
K942488	MEDCUFF	Aug 23, 1994	Substantially Equivalent	MED-CON, INC.
K942777	MINIMUS II; MINIMUS II COLOR; BABYPHON	Jul 27, 1994	Substantially Equivalent	RUDOLF RIESTER GMBH & CO. KG
K936313	CMS-90 BLOOD PRESSURE MEASUREMENT ASSISTANT	Jul 20, 1994	Substantially Equivalent	PREVENTION SCIENCES
K940493	HAND ANEROID SPHYGMOMANOMETER	Jul 01, 1994	Substantially Equivalent	WELCH ALLYN, INC.
K940214	STATCORP INC. DISPOSABLE BLOOD PRESSURE CUFF	Feb 22, 1994	Substantially Equivalent	STATCORP, INC.
K925297	RI-MED	Jan 14, 1994	Substantially Equivalent	RUDOLF RIESTER GMBH & CO. KG
K934180	SLIMLINE 3000	Nov 24, 1993	Substantially Equivalent	PYMAH CORP.
K932851	DISPOSABLE PENILE BLOOD PRESSURE CUFFS	Nov 15, 1993	Substantially Equivalent	D. E. HOKANSON, INC.
K925744	TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF	Jul 30, 1993	Substantially Equivalent	PYMAH CORP.
K931087	CLEANCUFF(TM)	May 27, 1993	Substantially Equivalent	MED-CON, INC.
K930604	BALANCED(TM) NYLON BLADDER	Apr 30, 1993	Substantially Equivalent	PYMAH CORP.
K925352	CLEAN CUFF BLOOD PRESSURE CUFF LINER	Jan 12, 1993	Substantially Equivalent	STERIDYNE CORP.
K921997	CUFF-M	Jul 23, 1992	Substantially Equivalent	LORIN MEDICAL, INC.
K911213	CUFFABLE	Aug 07, 1991	Substantially Equivalent	BIOMEDICAL DYNAMICS, INC.
K912638	BLOOD PRESSURE CUFFS	Jul 25, 1991	Substantially Equivalent	VITAL SIGNS, INC.
K912007	BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF	Jul 22, 1991	Substantially Equivalent	TECNADYNE SCIENTIFIC, INC.
K910903	INFLATE-A-CUFF #7014	May 08, 1991	Substantially Equivalent	PA MEDICAL CORP.
K905147	ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS	Dec 27, 1990	Substantially Equivalent	HEWLETT-PACKARD CO.
K905101	NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF	Dec 20, 1990	Substantially Equivalent	HEWLETT-PACKARD CO.
K903379	PYMAH PRE-GAGED BALANCED TEMPA-KUFF	Oct 19, 1990	Substantially Equivalent	PYMAH CORP.
K901252	HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS	Jul 31, 1990	Substantially Equivalent	HEWLETT-PACKARD CO.
K902132	CUFF, BLOOD PRESSURE	Jun 29, 1990	Substantially Equivalent	BUFFALO MEDICAL SPECIALTIES MFG., INC.
K901506	ANEROID SPHYGMOMANOMETER, DOCTOR TYPE	May 09, 1990	Substantially Equivalent	YAMASU CO. LTD.
K896986	BLOOD PRESSURE CUFF	Mar 06, 1990	Substantially Equivalent	LATEX MEDICAL DEVICES, INC.
K896788	DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF	Jan 19, 1990	Substantially Equivalent	ADVANCED MEDICAL INSTRUMENTS, INC.
K883977	SURGI-CUF STERILE/NON-STERILE DISPOSABLE	Feb 10, 1989	Substantially Equivalent	ETHOX CORP.
K884421	PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT	Jan 13, 1989	Substantially Equivalent	PYMAH CORP.
K881799	BLOOD PRESSURE CUFF	Oct 14, 1988	Substantially Equivalent	BIOMEDICAL DYNAMICS, INC.
K882121	C-FLO SUCTION TUBE	Jun 20, 1988	Substantially Equivalent	CONCEPT, INC.
K874233	BLOOD PRESSURE SLEEVE W/TUBING	Mar 22, 1988	Substantially Equivalent	DEVCOM, INC.
K874939	SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED	Feb 02, 1988	Substantially Equivalent for Some Indications	KIRSCHNER MEDICAL CORP.
K872144	MODIFIED DIGITAL BLOOD PRESSURE/PULSE METER	Jul 29, 1987	Substantially Equivalent	VESTRA-SUBCO, INC.
K854813	MEDNOVA BLOOD PRESSURE CUFF	Jun 20, 1986	Substantially Equivalent	MEDNOVA CORP.
K854023	NORELCO ELECTRONIC DIGITAL BP METER HC3501	Mar 26, 1986	Substantially Equivalent	PHILIPS PARK
K854752	THE CALIFORNIA SPLINT	Dec 17, 1985	Substantially Equivalent	INTL. MEDICATION SYSTEMS, LTD.
K852193	POROCOAT SCHATZKER II ACETABULUM	Jul 30, 1985	Substantially Equivalent for Some Indications	DEPUY, INC.
K852964	P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION	Jul 29, 1985	Substantially Equivalent	HOWMEDICA CORP.
K851565	HOMEDICA CEMENTED ACETABULAR COMPONENT 6262	Jul 19, 1985	Substantially Equivalent	HOWMEDICA CORP.
K844988	ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS.	Apr 04, 1985	Substantially Equivalent	ETHOX CORP.
K831001	UNICUFF-BLOOD PRESSURE CUFF	Jul 28, 1983	Substantially Equivalent	FRONTIER PRODUCTS
K831393	VASCULAB BLOOD PRESSURE CUFF	Jun 16, 1983	Substantially Equivalent	MEDASONICS, INC.
K831479	METAL-BACKED ACETABULAR CUP	Jun 15, 1983	Substantially Equivalent	DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K823843	FREEMAN ACETABULAR CUP	Mar 29, 1983	Substantially Equivalent	DEPUY, INC.
K830097	AUFRANC-TURNER ATS METAL BACKED ACETABU	Jan 28, 1983	Substantially Equivalent	HOWMEDICA CORP.
K821095	SPHYGURITE	Jun 10, 1982	Substantially Equivalent	ASSOCIATED MEDICAL DEVICES, INC.
K821232	ONE HAND ANEROID SPHYGMOMANOMETER	May 25, 1982	Substantially Equivalent	ABCO DEALERS, INC.
K820539	RELIEVED REINFORCED CUP	Mar 15, 1982	Substantially Equivalent	BIOMET, INC.
K813303	CONPHAR, WALL ANEROID SPHYGMOMANOMETER	Jan 22, 1982	Substantially Equivalent	CONPHAR, INC.
K813302	CONPHAR PALM ANEROID SPHYGMOMANOMETER	Jan 22, 1982	Substantially Equivalent	CONPHAR, INC.
K813323	THIGH CUFF: X-LARGE CUFF	Dec 29, 1981	Substantially Equivalent	ABCO DEALERS, INC.
K812946	TRONZO HIP	Nov 06, 1981	Substantially Equivalent	BIOMET, INC.
K811634	NORELCO ANEROID BLOOD PRESSURE METER	Jun 30, 1981	Substantially Equivalent	NORTH AMERICAN PHILIPS CORP.
K810838	NEONATAL BLOOD PRESSURE CUFF	Apr 03, 1981	Substantially Equivalent	INVIVO RESEARCH LABS, INC.
K810008	ALP-KII	Jan 16, 1981	Substantially Equivalent	MARTIN'S MAINE EXCHANGE
K801568	SHIELD DISPOSABLE BLOOD PRESSURE CUFF	Jul 28, 1980	Substantially Equivalent	AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
K801188	CONPHAR DESK TOP MERCURY SPHYGMOMAN	Jun 09, 1980	Substantially Equivalent	CONPHAR, INC.
K801186	CONPHAR DELUXE ANEROID SPHYGMOMANOMETER	Jun 09, 1980	Substantially Equivalent	CONPHAR, INC.
K801182	CONPHAR WALL MODEL MERCURY SPHYGMOMAN.	Jun 04, 1980	Substantially Equivalent	CONPHAR, INC.
K801099	UNICUF, BLOOD PRESSURE CUFF	May 30, 1980	Substantially Equivalent	FRONTIER PRODUCTS
K800767	MOD. MCI 17 MANUAL CUFF INFLATOR	Apr 24, 1980	Substantially Equivalent	MEDASONICS, INC.
K800236	ABCO MERCURIAL SPHYGMOMANOMETER	Feb 22, 1980	Substantially Equivalent	ABCO DEALERS, INC.
K792355	ANEROID SPHYMOMANOMETER	Dec 05, 1979	Substantially Equivalent	ABCO DEALERS, INC.
K792108	CONPHAR BLOOD PRESSURE CUFFS	Dec 04, 1979	Substantially Equivalent	CONPHAR, INC.
K791875	PARKE-DAVIS TOTAL HIP PROSTHESIS	Oct 04, 1979	Substantially Equivalent	WARNER-LAMBERT CO.
K790810	DISPOSA-CUF	May 25, 1979	Substantially Equivalent	CREST MEDICAL EQUIPMENT
K781671	BLOOD PRESSURE CUFF COVER	Nov 16, 1978	Substantially Equivalent	DAVID COTT CO.
K780715	ANEROID TYPE BLOOD PRESSURE KIT	Jul 17, 1978	Substantially Equivalent	MARS METAL CO., LTD.
K771501	ANEROID SPHYGMOMETER	Aug 30, 1977	Substantially Equivalent	SWARTZ MEDICAL EQUIPMENT
K760655	ANEROID SPHYGMOMANOMETER	Oct 05, 1976	Substantially Equivalent	ABCO DEALERS, INC.
K760157	SPHYGMOMANOMETER	Jul 19, 1976	Substantially Equivalent	EYVIRCO

FEI Numbers

This FDA classification entry is associated with 175 FEI numbers. Click on an entry to view related FDA registrations.

1000110823: 21 registrations

1000112877: 433 registrations

1000112968: 424 registrations

1000114111: 152 registrations

1000120897: 10 registrations

1000122497: 11 registrations

1000122786: 38 registrations

1000125241: 35 registrations

1000137528: 104 registrations

1000143485: 62 registrations

1000222013: 1 registration

1000292048: 59 registrations

1000379039: 27 registrations

1000403400: 19 registrations

1000589001: 14 registrations

1036863: 6 registrations

1043214: 577 registrations

1218950: 64 registrations

1220908: 21 registrations

1316463: 77 registrations

1417592: 699 registrations

1430016: 8 registrations

1450057: 48 registrations

1713468: 54 registrations

1720747: 220 registrations

1832894: 34 registrations

1937397: 17 registrations

2022648: 34 registrations

2025816: 30 registrations

2081040: 16 registrations

2412762: 3 registrations

2434008: 69 registrations

2523865: 215 registrations

2939520: 34 registrations

3000126629: 658 registrations

3000204983: 11 registrations

3000279201: 26 registrations

3000953362: 13 registrations

3001104093: 90 registrations

3001570235: 18 registrations

3002118752: 4 registrations

3002807167: 118 registrations

3002807736: 5 registrations

3002865611: 1 registration

3003074886: 23 registrations

3003171455: 8 registrations

3003247551: 2 registrations

3003622639: 26 registrations

3003674698: 69 registrations

3003741676: 41 registrations

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3003864328: 18 registrations

3003965134: 115 registrations

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3005616800: 2 registrations

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3006113277: 12 registrations

3006157842: 56 registrations

3006252153: 19 registrations

3006441164: 6 registrations

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3007307487: 24 registrations

3007407626: 34 registrations

3007699081: 9 registrations

3007699082: 9 registrations

3007703436: 45 registrations

3007740533: 29 registrations

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3008729547: 71 registrations

3008962161: 2 registrations

3009077524: 178 registrations

3009154535: 3 registrations

3009191551: 7 registrations

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3009490946: 24 registrations

3009512503: 31 registrations

3009560891: 10 registrations

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3009888765: 5 registrations

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3010262192: 13 registrations

3010272829: 52 registrations

3010362947: 6 registrations

3010432890: 119 registrations

3010521050: 4 registrations

3010605677: 176 registrations

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3011353843: 55 registrations

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3011713222: 10 registrations

3012104670: 72 registrations

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3013319212: 78 registrations

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3013517171: 71 registrations

3013557562: 654 registrations

3013783488: 23 registrations

3014233600: 7 registrations

3014345698: 17 registrations

3014421917: 283 registrations

3014527907: 3 registrations

3014541700: 17 registrations

3014579161: 117 registrations

3015007456: 6 registrations

3015058854: 133 registrations

3015220324: 4 registrations

3015422337: 25 registrations

3015544945: 13 registrations

3015616170: 4 registrations

3015895045: 215 registrations

3015997711: 72 registrations

3016170451: 14 registrations

3016452327: 28 registrations

3016618143: 63 registrations

3016674095: 11 registrations

3016701404: 34 registrations

3016774562: 28 registrations

3016904853: 78 registrations

3017150478: 1 registration

3017178358: 13 registrations

3017303999: 17 registrations

3017618680: 2 registrations

3017619536: 7 registrations

3018101395: 2 registrations

3019130: 10 registrations

3019388613: 52 registrations

3020460367: 78 registrations

3022764531: 6 registrations

3026408938: 290 registrations

3029923680: 8 registrations

3030446844: 160 registrations

3030447506: 78 registrations

3031192529: 1 registration

3033530427: 33 registrations

3033536319: 44 registrations

3033919392: 8 registrations

3926: 103 registrations