DRS · Transducer, Blood-Pressure, Extravascular
Cardiovascular · 21 CFR 870.2850 · Class 2
Overview
| Product Code | DRS |
|---|---|
| Device Name | Transducer, Blood-Pressure, Extravascular |
| Regulation | 21 CFR 870.2850 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | Mar 21, 2025 | SESE |
| K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | Merit Medical Pte. , Ltd. | Mar 17, 2023 | SESE |
| K172458 | 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 | 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 | Compass Cast and MAP | Centurion Medical Products Corporation | Nov 22, 2016 | SESE |
| K152472 | Disposable Pressure Transducer | Zhejiang Haisheng Medical Device Co., Ltd. | Oct 31, 2016 | SESE |
| K152980 | Flo Trac sensor, Volume View sensor | Edwards Lifesciences, LLC | Jan 19, 2016 | SESE |
| K151040 | 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 | COMPASS CT, COMPASS CT PORT | Mirador Biomedical | Apr 18, 2014 | SESE |
| K123095 | MEDLINE BLOOD PRESSURE TRANSDUCER | Medline Industries, Inc. | May 8, 2013 | SESE |
| K120624 | ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) | Elcam Medical Acal | Jun 8, 2012 | SESE |
| K112203 | COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST | Mirador Biomedical, Inc. | Dec 14, 2011 | SESE |
| K102033 | COMBITRANS MONITORING SETS AND ACCESSORIES | B.Braun Melsungen AG | Apr 7, 2011 | SESE |
| K103715 | COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE | Mirador Biomedical, Inc. | Jan 20, 2011 | SESE |
| K101189 | REAVILLMED PRESSURE MONITORING SYSTEM AND PICC | Reavillmed | Dec 22, 2010 | SESE |
| K101518 | COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE | Mirador Biomedical, Inc. | Oct 13, 2010 | SESE |
| K092644 | TERUMO PRESSURE ISOLATOR | Terumo Cardiovascular Systems Corp. | Dec 10, 2009 | SESE |
| K091408 | DISPOSABLE PRESSURE TRANSDUCER | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | Aug 18, 2009 | SESE |
| K070710 | ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM | Biosensors International-USA | Apr 19, 2007 | SESE |
| K062342 | 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
