Product code DRS

Device name: Transducer, Blood-Pressure, Extravascular
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.2850
Review panel: CV
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K242909	FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors	Edwards Lifesciences, LLC	2025-03-21
K221782	Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes	Merit Medical Pte. , Ltd.	2023-03-17
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.	2017-11-09
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.	2017-05-24
K161408	Compass Cast and MAP	Centurion Medical Products Corporation	2016-11-22
K152472	Disposable Pressure Transducer	Zhejiang Haisheng Medical Device Co., Ltd.	2016-10-31
K152980	Flo Trac sensor, Volume View sensor	Edwards Lifesciences, LLC	2016-01-19
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.	2015-09-04
K133624	COMPASS CT, COMPASS CT PORT	Mirador Biomedical	2014-04-18
K123095	MEDLINE BLOOD PRESSURE TRANSDUCER	Medline Industries, Inc.	2013-05-08
K120624	ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)	Elcam Medical Acal	2012-06-08
K112203	COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST	Mirador Biomedical, Inc.	2011-12-14
K102033	COMBITRANS MONITORING SETS AND ACCESSORIES	B.Braun Melsungen AG	2011-04-07
K103715	COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE	Mirador Biomedical, Inc.	2011-01-20
K101189	REAVILLMED PRESSURE MONITORING SYSTEM AND PICC	Reavillmed	2010-12-22
K101518	COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE	Mirador Biomedical, Inc.	2010-10-13
K092644	TERUMO PRESSURE ISOLATOR	Terumo Cardiovascular Systems Corp.	2009-12-10
K091408	DISPOSABLE PRESSURE TRANSDUCER	Shenzhen Ant Hi-Tech Industrial Co., Ltd.	2009-08-18
K070710	ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM	Biosensors International-USA	2007-04-19
K062342	TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT	Sentra Medical Devices, LLC	2006-09-25
K061573	TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT	Hospira, Inc.	2006-09-19
K052828	DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)	Hospira, Inc.	2006-02-17
K043065	VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P	Edwards Lifesciences, LLC	2005-01-26
K983372	BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP	Sunscope Intl., Inc.	1999-02-05
K981747	BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX	Sunscope Intl., Inc.	1998-08-20
K981745	BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX	Sunscope Intl., Inc.	1998-07-17
K961404	MX960 REUSABLE PRESSURE TRANSDUCER	Medex, Inc.	1996-06-27
K951722	PERCEPTOR COMPENSATOR MORSE MANIFOLD	Namic	1996-03-25
K951129	NOVATRANS II	Medex, Inc.	1995-04-05
K930888	WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM	Ralin Medical, Inc.	1993-07-21

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00885403531678	Acumen IQ, VAMP	Becton, Dickinson And Company	2026-05-30
00885403531739	Acumen IQ	Becton, Dickinson And Company	2026-05-30
00885403531654	Acumen IQ	Becton, Dickinson And Company	2026-05-30
H6719020230	DELTRAN	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6719020110	DELTRAN	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6719020080	DELTRAN	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6719015960	DELTRAN	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6719004920	DELTRAN	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6716004000	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6716001220	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6716001020	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6716001010	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713100840	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713100720	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713100600	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713100480	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713100360	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713100240	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713100180	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713100120	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713100060	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713000840	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713000720	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713000600	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713000480	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713000360	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713000240	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713000180	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713000120	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23
H6713000060	N/A	UTAH MEDICAL PRODUCTS, INC.	2016-09-23

Product code DRS

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