DRS — Transducer, Blood-Pressure, Extravascular

Class 2

Medical Specialty

Review Panel

Submission Type

FDA Authorisations (148)

Device Name	Manufacturer	K-Number	Decision Date
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors	Edwards Lifesciences, LLC	K242909	2025-03-21
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes	Merit Medical Pte. , Ltd.	K221782	2023-03-17
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit	Smiths Medical Asd, Inc.	K172458	2017-11-09
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit	Smiths Medical Asd, Inc.	K163172	2017-05-24
Compass Cast and MAP	Centurion Medical Products Corporation	K161408	2016-11-22
Disposable Pressure Transducer	Zhejiang Haisheng Medical Device Co., Ltd.	K152472	2016-10-31
Flo Trac sensor, Volume View sensor	Edwards Lifesciences, LLC	K152980	2016-01-19
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.	K151040	2015-09-04
COMPASS CT, COMPASS CT PORT	Mirador Biomedical	K133624	2014-04-18
MEDLINE BLOOD PRESSURE TRANSDUCER	Medline Industries, Inc.	K123095	2013-05-08
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)	Elcam Medical Acal	K120624	2012-06-08
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST	Mirador Biomedical, Inc.	K112203	2011-12-14
COMBITRANS MONITORING SETS AND ACCESSORIES	B.Braun Melsungen AG	K102033	2011-04-07
COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE	Mirador Biomedical, Inc.	K103715	2011-01-20
REAVILLMED PRESSURE MONITORING SYSTEM AND PICC	Reavillmed	K101189	2010-12-22
COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE	Mirador Biomedical, Inc.	K101518	2010-10-13
TERUMO PRESSURE ISOLATOR	Terumo Cardiovascular Systems Corp.	K092644	2009-12-10
DISPOSABLE PRESSURE TRANSDUCER	Shenzhen Ant Hi-Tech Industrial Co., Ltd.	K091408	2009-08-18
ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM	Biosensors International-USA	K070710	2007-04-19
TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT	Sentra Medical Devices, LLC	K062342	2006-09-25

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