Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2850](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2850) → DRS — Transducer, Blood-Pressure, Extravascular # DRS · Transducer, Blood-Pressure, Extravascular _Cardiovascular · 21 CFR 870.2850 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS ## Overview - **Product Code:** DRS - **Device Name:** Transducer, Blood-Pressure, Extravascular - **Regulation:** [21 CFR 870.2850](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2850) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 148) Showing 20 most recent of 148 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242909](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K242909.md) | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | Mar 21, 2025 | SESE | | [K221782](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K221782.md) | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | Merit Medical Pte. , Ltd. | Mar 17, 2023 | SESE | | [K172458](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K172458.md) | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | Smiths Medical Asd, Inc. | Nov 9, 2017 | SESE | | [K163172](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K163172.md) | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | Smiths Medical Asd, Inc. | May 24, 2017 | SESE | | [K161408](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K161408.md) | Compass Cast and MAP | Centurion Medical Products Corporation | Nov 22, 2016 | SESE | | [K152472](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K152472.md) | Disposable Pressure Transducer | Zhejiang Haisheng Medical Device Co., Ltd. | Oct 31, 2016 | SESE | | [K152980](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K152980.md) | Flo Trac sensor, Volume View sensor | Edwards Lifesciences, LLC | Jan 19, 2016 | SESE | | [K151040](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K151040.md) | Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer | Biometrix , Ltd. | Sep 4, 2015 | SESE | | [K133624](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K133624.md) | COMPASS CT, COMPASS CT PORT | Mirador Biomedical | Apr 18, 2014 | SESE | | [K123095](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K123095.md) | MEDLINE BLOOD PRESSURE TRANSDUCER | Medline Industries, Inc. | May 8, 2013 | SESE | | [K120624](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K120624.md) | ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) | Elcam Medical Acal | Jun 8, 2012 | SESE | | [K112203](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K112203.md) | COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST | Mirador Biomedical, Inc. | Dec 14, 2011 | SESE | | [K102033](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K102033.md) | COMBITRANS MONITORING SETS AND ACCESSORIES | B.Braun Melsungen AG | Apr 7, 2011 | SESE | | [K103715](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K103715.md) | COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE | Mirador Biomedical, Inc. | Jan 20, 2011 | SESE | | [K101189](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K101189.md) | REAVILLMED PRESSURE MONITORING SYSTEM AND PICC | Reavillmed | Dec 22, 2010 | SESE | | [K101518](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K101518.md) | COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE | Mirador Biomedical, Inc. | Oct 13, 2010 | SESE | | [K092644](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K092644.md) | TERUMO PRESSURE ISOLATOR | Terumo Cardiovascular Systems Corp. | Dec 10, 2009 | SESE | | [K091408](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K091408.md) | DISPOSABLE PRESSURE TRANSDUCER | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | Aug 18, 2009 | SESE | | [K070710](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K070710.md) | ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM | Biosensors International-USA | Apr 19, 2007 | SESE | | [K062342](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS/K062342.md) | TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT | Sentra Medical Devices, LLC | Sep 25, 2006 | SESE | ## Top Applicants - Medex, Inc. — 7 clearances - Sorensen Research — 7 clearances - Gould, Inc. — 6 clearances - Transamerica Delaval, Inc. — 6 clearances - Hewlett-Packard Co. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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