Product Code: DSK FDA class 2 21 CFR 870.1110

Computer, Blood-Pressure

Cardiovascular

The Blood-Pressure Computer is a cardiovascular computing device used to calculate, process, and display blood pressure values and related hemodynamic parameters from pressure transducer signals during patient monitoring. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSK and it is regulated under 21 CFR 870.1110 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DSK
Device Class: FDA class 2
Regulation Number: 870.1110
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 77 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K231586	Endophys Blood Pressure Monitor model BPM-30	Nov 03, 2023	Substantially Equivalent	Endophys Technologies, LLC
K160945	Endophys Blood Pressure Monitor	Sep 26, 2016	Substantially Equivalent	Endophys Holdings, LLC
K152582	CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box	Dec 03, 2015	Substantially Equivalent	Volcano Corporation
K141615	ENDOPHYS BLOOD PRESSURE MONITOR	Jan 07, 2015	Substantially Equivalent	Endophys, Inc.
K080670	MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM	Apr 23, 2008	Substantially Equivalent	Atcor Medical
K070795	SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM	Aug 31, 2007	Substantially Equivalent	Atcor Medical Pty, Ltd.
K033738	MONITORING SYSTEM, MODEL ARGUS PB-2200	Aug 24, 2004	Substantially Equivalent	Schiller AG
K021517	ABP FOR WINDOWS	Jul 24, 2002	Substantially Equivalent	Rozinn Electronics, Inc.
K013943	RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720	Dec 18, 2001	Substantially Equivalent	Radi Medical Systems AB
K011865	ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION	Jul 31, 2001	Substantially Equivalent	Zoll Medical Corp
K003122	SMARTFLOW, MODEL SFIP 2000	May 14, 2001	Substantially Equivalent	Florence Medical , Ltd.
K002742	SPHYGMOCOR MX MODEL SCOR-MX	May 01, 2001	Substantially Equivalent	Pwv Medical Pty, Lt.
K002067	RADIANALYZER, MODEL 12710	Jan 11, 2001	Substantially Equivalent	Radi Medical Systems AB
K983250	INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR	Dec 12, 1999	Substantially Equivalent	Magnetic Resonance Equipment Corp.
K951226	VITALMAX 4000/MINIPACK 3100/3000	Nov 21, 1996	Substantially Equivalent	Pace Tech, Inc.
K943457	AS/3 PRESSURE TEMPERATURE MODULE, M-PT	Jul 27, 1994	Substantially Equivalent	Datex Division Instrumentarium Corp.
K921388	BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE	May 26, 1993	Substantially Equivalent	Biochem International, Inc.
K925899	AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01	May 21, 1993	Substantially Equivalent	Welch Allyn, Inc.
K914273	A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR	Feb 09, 1993	Substantially Equivalent	A&D Engineering, Inc.
K912816	PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE	Apr 10, 1992	Substantially Equivalent	S & W Medico Teknik
K912833	CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY	Sep 23, 1991	Substantially Equivalent	Camino Laboratories, Inc.
K903900	SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.	Jan 08, 1991	Substantially Equivalent	Ppg Hellige B.V.
K901514	XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.	Nov 16, 1990	Substantially Equivalent	Ppg Industries, Inc.
K896535	MEDILOG OPTIMA	Jan 18, 1990	Substantially Equivalent	Oxford Medilog, Inc.
K893232	MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM	Jul 14, 1989	Substantially Equivalent	Camino Laboratories, Inc.
K884118	TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA	Apr 25, 1989	Substantially Equivalent	S & W Medico Teknik
K884938	VITAL SIGNS MONITOR	Apr 19, 1989	Substantially Equivalent	Tico Medical Instruments, Inc.
K885235	SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.	Jan 25, 1989	Substantially Equivalent	Spectramed, Inc.
K882093	CARDIOCAP(TM) CMO-104 MONITOR	Jul 28, 1988	Substantially Equivalent	Datex Division Instrumentarium Corp.
K882085	PROPAQ 104(TM)	Jul 28, 1988	Substantially Equivalent	Protocol Systems, Inc.
K880079	TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420	Mar 31, 1988	Substantially Equivalent	A&D Engineering, Inc.
K874338	TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610	Feb 05, 1988	Substantially Equivalent	A&D Engineering, Inc.
K874339	TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620	Dec 18, 1987	Substantially Equivalent	A&D Engineering, Inc.
K873765	FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER	Oct 09, 1987	Substantially Equivalent	Nam Tai , Ltd.
K871720	MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER	Jul 29, 1987	Substantially Equivalent	A&D Engineering, Inc.
K871718	MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER	Jun 24, 1987	Substantially Equivalent	A&D Engineering, Inc.
K863042	SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR	Jan 14, 1987	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K862200	FORTEC MI-100, BLOOD PRESSURE METER	Nov 18, 1986	Substantially Equivalent	Fortec Electronic Corp./Nam Tai
K862455	MODIFIED CARDIOCAP MONITOR	Sep 24, 1986	Substantially Equivalent	Datex Division Instrumentarium Corp.
K862647	PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403	Aug 18, 1986	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K860689	SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE	Jul 30, 1986	Substantially Equivalent	Spacelabs, Inc.
K850879	HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR	Apr 25, 1985	Substantially Equivalent	Mennen Medical, Inc.
K844397	POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000	Apr 18, 1985	Substantially Equivalent	Associated Mills, Inc.
K844396	POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000	Apr 18, 1985	Substantially Equivalent	Associated Mills, Inc.
K832017	LME BLOOD PRESSURE MONITOR	Oct 31, 1983	Substantially Equivalent	Litton Medical Electronics
K831481	DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN	Oct 04, 1983	Substantially Equivalent	Eugene Scarberry
K822843	HTS *1	Dec 15, 1982	Substantially Equivalent	Global Office Automation System, Inc.
K822878	MODEL 78553A PRESSURE PLUG-IN MODULE	Oct 18, 1982	Substantially Equivalent	Hewlett-Packard Co.
K811148	VITA-STAT MODEL 9000-S	Jun 30, 1981	Substantially Equivalent	Viat-Stat
K811147	VITA-STAT MODEL 9000-A	Jun 30, 1981	Substantially Equivalent	Vita-Stat
K811146	VITA-STAT MODEL 8000-C	Jun 30, 1981	Substantially Equivalent	Vita-Stat
K811079	SYPHGMOLOG	Jun 12, 1981	Substantially Equivalent	Cardiodyne General, Inc.
K811208	MODEL 1100 SPHYGMOMANOMETER	May 21, 1981	Substantially Equivalent	Y
K810635	ELECTRODE BLOOD PRESSURE MONITOR	May 08, 1981	Substantially Equivalent	Sears, Roebuck & Co.
K810179	DUAL TRACE PATIENT MONITOR 116,118,120	Feb 25, 1981	Substantially Equivalent	Honeywell, Inc.
K810178	PATIENT MONITOR CM111, 112	Feb 25, 1981	Substantially Equivalent	Honeywell, Inc.
K810172	PRESSURE FUNCTION BLOCKS	Feb 25, 1981	Substantially Equivalent	Honeywell, Inc.
K810171	PERIPHERAL PULSE FUNCTION BLOCKS	Feb 25, 1981	Substantially Equivalent	Honeywell, Inc.
K802925	6-415 FILTER, ELEMENT, 170-C	Dec 19, 1980	Substantially Equivalent	Lifecare Services, Inc.
K802600	AMP PORTABLE PATIENT PRESSURE MONITOR	Nov 12, 1980	Substantially Equivalent	American Medical Products, Inc.
K801110	PRESSURE MONITOR, MODEL 1131B	May 20, 1980	Substantially Equivalent	American Optical Corp.
K800360	OUTPUT DIGITAL DISPLAY MODULE, MOD. 611	Feb 29, 1980	Substantially Equivalent	Output, Inc.
K792077	MODEL 1981 PRESSUROMETER DATA ANALYSIS	Dec 04, 1979	Substantially Equivalent	Del Mar Avionics
K791839	H59 CRITICAL CARE MONITOR	Oct 01, 1979	Substantially Equivalent	Medtel Pty. , Ltd.
K791838	HSH/H512 ADULT PHYSIOLOGICAL MONITORS	Oct 01, 1979	Substantially Equivalent	Medtel Pty. , Ltd.
K782073	DINAMAP MODELS 1160 AND 1165	Feb 23, 1979	Substantially Equivalent	Applied Medical Research
K790135	MONITOR, PRESSURVEIL	Feb 13, 1979	Substantially Equivalent	Concept, Inc.
K781701	BLOOD PRESSURE, DIGITAL MODEL #2153	Dec 04, 1978	Substantially Equivalent	Sears, Roebuck & Co.
K781064	DINAMAP MODEL 848	Sep 07, 1978	Substantially Equivalent	Applied Medical Research
K781053	DINAMAP MODEL 846	Sep 07, 1978	Substantially Equivalent	Applied Medical Research
K780798	GOULD-STATHAM SP1405 PRESSURE MONITOR	Jun 13, 1978	Substantially Equivalent	Gould, Inc.
K780356	OUTPUT DIGITAL DISPLAY MODULE, MODEL 401	May 31, 1978	Substantially Equivalent	Output, Inc.
K772334	MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP	Feb 21, 1978	Substantially Equivalent	Telectronics, Inc.
K771981	MINIMAP MODEL 810	Jan 24, 1978	Substantially Equivalent	Applied Medical Research
K772234	CARDIAC OUTPUT MODULE-78231C	Jan 05, 1978	Substantially Equivalent	Hewlett-Packard Co.
K771977	CARDIAC OUTPUT COMPUTER MODEL 701	Jan 03, 1978	Substantially Equivalent	Instrumentation Laboratory CO
K771772	DINAMAP MODEL 825A	Oct 04, 1977	Substantially Equivalent	Applied Medical Research