Computer, Blood-Pressure
FDA product code DSK · Class II (moderate risk) · 21 CFR 870.1110 · Cardiovascular
77510(k) clearances
0PMA approvals
1recalls
Manufacturers
- A&D Engineering, Inc. 6
- Applied Medical Research 5
- Honeywell, Inc. 4
- Datex Division Instrumentarium Corp. 3
- S & W Medico Teknik 2
- Associated Mills, Inc. 2
- Atcor Medical 2
- Vita-Stat 2
- Camino Laboratories, Inc. 2
- Radi Medical Systems AB 2
- Medtel Pty. , Ltd. 2
- Sears, Roebuck & Co. 2
- Output, Inc. 2
- Hewlett-Packard Co. 2
- American Optical Corp. 1
- American Medical Products, Inc. 1
- Lifecare Services, Inc. 1
- Concept, Inc. 1
- Gould, Inc. 1
- Endophys Technologies, LLC 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30DSK · Traditional | Endophys Technologies, LLC | 11/03/2023SE |
| K160945 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys Holdings, LLC | 09/26/2016SE |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxDSK · Special | Volcano Corporation | 12/03/2015SE |
| K141615 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys, Inc. | 01/07/2015SE |
| K080670 | Modification to Sphygmocor Cardiovascular Management SystemDSK · Special | Atcor Medical | 04/23/2008SE |
| K070795 | Sphygmocor Cardiovascular Management SystemDSK · Traditional | Atcor Medical Pty, Ltd. | 08/31/2007SE |
| K033738 | Monitoring System, Model Argus PB-2200DSK · Traditional | Schiller AG | 08/24/2004SE |
| K021517 | Abp for WindowsDSK · Traditional | Rozinn Electronics, Inc. | 07/24/2002SE |
| K013943 | Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720DSK · Special | Radi Medical Systems AB | 12/18/2001SE |
| K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature OptionDSK · Traditional | Zoll Medical Corp | 07/31/2001SE |
| K003122 | Smartflow, Model Sfip 2000DSK · Traditional | Florence Medical , Ltd. | 05/14/2001SE |
| K002742 | Sphygmocor MX Model Scor-MxDSK · Traditional | Pwv Medical Pty, Lt. | 05/01/2001SE |
| K002067 | Radianalyzer, Model 12710DSK · Traditional | Radi Medical Systems AB | 01/11/2001SE |
| K983250 | Invasive Blood Pressure (Ibp) Function, Model 9500 Multigas MonitorDSK · Traditional | Magnetic Resonance Equipment Corp. | 12/12/1999SE |
| K951226 | Vitalmax 4000/MINIPACK 3100/3000DSK · Traditional | Pace Tech, Inc. | 11/21/1996SE |
| K943457 | AS/3 Pressure Temperature Module, M-PtDSK · Traditional | Datex Division Instrumentarium Corp. | 07/27/1994SE |
| K921388 | Biochem 9100 Multigas Monitor Ibp ModuleDSK · Traditional | Biochem International, Inc. | 05/26/1993SE |
| K925899 | Ambulatory Blood Pressure Monitor, Mdl# 5100-01DSK · Traditional | Welch Allyn, Inc. | 05/21/1993SE |
| K914273 | A&D TM-2421/2021 Ambulatory Blood Pressure MonitorDSK · Traditional | A&D Engineering, Inc. | 02/09/1993SE |
| K912816 | Press 1 Press 2 9220 Updating of the ModuleDSK · Traditional | S & W Medico Teknik | 04/10/1992SE |
| K912833 | Camino Model M420: Monit Inter W/Mean Pres DisplayDSK · Traditional | Camino Laboratories, Inc. | 09/23/1991SE |
| K903900 | Smu 611 Vers. 2.0 Including Pressni,Dilu,Sat-Mod.DSK · Traditional | Ppg Hellige B.V. | 01/08/1991SE |
| K901514 | XR Model H Physiological Monitor & Recording Sys.DSK · Traditional | Ppg Industries, Inc. | 11/16/1990SE |
| K896535 | Medilog OptimaDSK · Traditional | Oxford Medilog, Inc. | 01/18/1990SE |
| K893232 | Model V420 Direct Pressure Monitor & 427 WaveformDSK · Traditional | Camino Laboratories, Inc. | 07/14/1989SE |
| K884118 | Type 9220 Press 1 & 2 System AthenaDSK · Traditional | S & W Medico Teknik | 04/25/1989SE |
| K884938 | Vital Signs MonitorDSK · Traditional | Tico Medical Instruments, Inc. | 04/19/1989SE |
| K885235 | Safe-Draw(Tm) Blood Sampling Reservoir & Access.DSK · Traditional | Spectramed, Inc. | 01/25/1989SE |
| K882093 | Cardiocap(Tm) CMO-104 MonitorDSK · Traditional | Datex Division Instrumentarium Corp. | 07/28/1988SE |
| K882085 | Propaq 104(TM)DSK · Traditional | Protocol Systems, Inc. | 07/28/1988SE |
| K880079 | Takeda Medical Auto. Ambu. Blood Press. METER/2420DSK · Traditional | A&D Engineering, Inc. | 03/31/1988SE |
| K874338 | Takeda Medical Blood Pressure Meter Model TM-2610DSK · Traditional | A&D Engineering, Inc. | 02/05/1988SE |
| K874339 | Takeda Medical Blood Pressure Meter Model TM-2620DSK · Traditional | A&D Engineering, Inc. | 12/18/1987SE |
| K873765 | Fortec MI-100, MI-50 Digital Blood Pressure MeterDSK · Traditional | Nam Tai , Ltd. | 10/09/1987SE |
| K871720 | Modified Model UA-731 Digital SphygmomanometerDSK · Traditional | A&D Engineering, Inc. | 07/29/1987SE |
| K871718 | Modified Model UA-711 Digital SphygmonometerDSK · Traditional | A&D Engineering, Inc. | 06/24/1987SE |
| K863042 | Sirecust 888/888R Non-Invasive Blood Press MonitorDSK · Traditional | Siemens Medical Solutions USA, Inc. | 01/14/1987SE |
| K862200 | Fortec MI-100, Blood Pressure MeterDSK · Traditional | Fortec Electronic Corp./Nam Tai | 11/18/1986SE |
| K862455 | Modified Cardiocap MonitorDSK · Traditional | Datex Division Instrumentarium Corp. | 09/24/1986SE |
| K862647 | Physiological Monitor, Models 401,402 & 403DSK · Traditional | Ivy Biomedical Systems, Inc. | 08/18/1986SE |
| K860689 | Spacelabs P.C. Cardiac Output/Pressure ModuleDSK · Traditional | Spacelabs, Inc. | 07/30/1986SE |
| K850879 | Horizon 2000 Physiological Patient MonitorDSK · Traditional | Mennen Medical, Inc. | 04/25/1985SE |
| K844397 | Pollenex Digital Sphygmomanometer BP-4000DSK · Traditional | Associated Mills, Inc. | 04/18/1985SE |
| K844396 | Pollenex Digital Sphygmomanometer BP-2000DSK · Traditional | Associated Mills, Inc. | 04/18/1985SE |
| K832017 | Lme Blood Pressure MonitorDSK · Traditional | Litton Medical Electronics | 10/31/1983SE |
| K831481 | Dixie USA PTL, Pharyngeal Tracheal LumenDSK · Traditional | Eugene Scarberry | 10/04/1983SE |
| K822843 | HTS *1DSK · Traditional | Global Office Automation System, Inc. | 12/15/1982SE |
| K822878 | Model 78553A Pressure Plug-In ModuleDSK · Traditional | Hewlett-Packard Co. | 10/18/1982SE |
| K811148 | Vita-Stat Model 9000-SDSK · Traditional | Viat-Stat | 06/30/1981SE |
| K811147 | Vita-Stat Model 9000-ADSK · Traditional | Vita-Stat | 06/30/1981SE |
| K811146 | Vita-Stat Model 8000-CDSK · Traditional | Vita-Stat | 06/30/1981SE |
| K811079 | SyphgmologDSK · Traditional | Cardiodyne General, Inc. | 06/12/1981SE |
| K811208 | Model 1100 SphygmomanometerDSK · Traditional | Y | 05/21/1981SE |
| K810635 | Electrode Blood Pressure MonitorDSK · Traditional | Sears, Roebuck & Co. | 05/08/1981SE |
| K810179 | Dual Trace Patient Monitor 116,118,120DSK · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K810178 | Patient Monitor CM111, 112DSK · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K810172 | Pressure Function BlocksDSK · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K810171 | Peripheral Pulse Function BlocksDSK · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K802925 | 6-415 Filter, Element, 170-CDSK · Traditional | Lifecare Services, Inc. | 12/19/1980SE |
| K802600 | Amp Portable Patient Pressure MonitorDSK · Traditional | American Medical Products, Inc. | 11/12/1980SE |
| K801110 | Pressure Monitor, Model 1131BDSK · Traditional | American Optical Corp. | 05/20/1980SE |
| K800360 | Output Digital Display Module, Mod. 611DSK · Traditional | Output, Inc. | 02/29/1980SE |
| K792077 | Model 1981 Pressurometer Data AnalysisDSK · Traditional | Del Mar Avionics | 12/04/1979SE |
| K791839 | H59 Critical Care MonitorDSK · Traditional | Medtel Pty. , Ltd. | 10/01/1979SE |
| K791838 | HSH/H512 Adult Physiological MonitorsDSK · Traditional | Medtel Pty. , Ltd. | 10/01/1979SE |
| K782073 | Dinamap Models 1160 and 1165DSK · Traditional | Applied Medical Research | 02/23/1979SE |
| K790135 | Monitor, PressurveilDSK · Traditional | Concept, Inc. | 02/13/1979SE |
| K781701 | Blood Pressure, Digital Model #2153DSK · Traditional | Sears, Roebuck & Co. | 12/04/1978SE |
| K781064 | Dinamap Model 848DSK · Traditional | Applied Medical Research | 09/07/1978SE |
| K781053 | Dinamap Model 846DSK · Traditional | Applied Medical Research | 09/07/1978SE |
| K780798 | Gould-Statham SP1405 Pressure MonitorDSK · Traditional | Gould, Inc. | 06/13/1978SE |
| K780356 | Output Digital Display Module, Model 401DSK · Traditional | Output, Inc. | 05/31/1978SE |
| K772334 | Monitor, Cardiac, W/Blood Press.&TempDSK · Traditional | Telectronics, Inc. | 02/21/1978SE |
| K771981 | Minimap Model 810DSK · Traditional | Applied Medical Research | 01/24/1978SE |
| K772234 | Cardiac Output MODULE-78231CDSK · Traditional | Hewlett-Packard Co. | 01/05/1978SE |
| K771977 | Cardiac Output Computer Model 701DSK · Traditional | Instrumentation Laboratory CO | 01/03/1978SE |
| K771772 | Dinamap Model 825ADSK · Traditional | Applied Medical Research | 10/04/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1946-2012 Class II | Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag…Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the… | Argon Medical Devices, Inc | 05/04/2012Terminated |