Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1110](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1110) → DSK — Computer, Blood-Pressure # DSK · Computer, Blood-Pressure _Cardiovascular · 21 CFR 870.1110 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK ## Overview - **Product Code:** DSK - **Device Name:** Computer, Blood-Pressure - **Regulation:** [21 CFR 870.1110](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1110) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 77) Showing 20 most recent of 77 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K231586](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K231586.md) | Endophys Blood Pressure Monitor model BPM-30 | Endophys Technologies, LLC | Nov 3, 2023 | SESE | | [K160945](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K160945.md) | Endophys Blood Pressure Monitor | Endophys Holdings, LLC | Sep 26, 2016 | SESE | | [K152582](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K152582.md) | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box | Volcano Corporation | Dec 3, 2015 | SESE | | [K141615](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K141615.md) | ENDOPHYS BLOOD PRESSURE MONITOR | Endophys, Inc. | Jan 7, 2015 | SESE | | [K080670](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K080670.md) | MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | Atcor Medical | Apr 23, 2008 | SESE | | [K070795](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K070795.md) | SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | Atcor Medical Pty, Ltd. | Aug 31, 2007 | SESE | | [K033738](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K033738.md) | MONITORING SYSTEM, MODEL ARGUS PB-2200 | Schiller AG | Aug 24, 2004 | SESE | | [K021517](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K021517.md) | ABP FOR WINDOWS | Rozinn Electronics, Inc. | Jul 24, 2002 | SESE | | [K013943](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K013943.md) | RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 | Radi Medical Systems AB | Dec 18, 2001 | SESE | | [K011865](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K011865.md) | ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION | Zoll Medical Corp | Jul 31, 2001 | SESE | | [K003122](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K003122.md) | SMARTFLOW, MODEL SFIP 2000 | Florence Medical , Ltd. | May 14, 2001 | SESE | | [K002742](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K002742.md) | SPHYGMOCOR MX MODEL SCOR-MX | Pwv Medical Pty, Lt. | May 1, 2001 | SESE | | [K002067](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K002067.md) | RADIANALYZER, MODEL 12710 | Radi Medical Systems AB | Jan 11, 2001 | SESE | | [K983250](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K983250.md) | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR | Magnetic Resonance Equipment Corp. | Dec 12, 1999 | SESE | | [K951226](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K951226.md) | VITALMAX 4000/MINIPACK 3100/3000 | Pace Tech, Inc. | Nov 21, 1996 | SESE | | [K943457](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K943457.md) | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | Datex Division Instrumentarium Corp. | Jul 27, 1994 | SESE | | [K921388](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K921388.md) | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE | Biochem International, Inc. | May 26, 1993 | SESE | | [K925899](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K925899.md) | AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 | Welch Allyn, Inc. | May 21, 1993 | SESE | | [K914273](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K914273.md) | A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR | A&D Engineering, Inc. | Feb 9, 1993 | SESE | | [K912816](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK/K912816.md) | PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE | S & W Medico Teknik | Apr 10, 1992 | SESE | ## Top Applicants - A&D Engineering, Inc. — 6 clearances - Applied Medical Research — 5 clearances - Honeywell, Inc. — 4 clearances - Datex Division Instrumentarium Corp. — 3 clearances - Associated Mills, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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