ClearanceBrief
Panels › Cardiovascular › Product code DRS · Class 2

Transducer, Blood-Pressure, Extravascular

Regulation 870.2850

1510(k)s in 12 months (149 all time)
2recalls in 12 months (236 all time)
226recalls that name a 510(k)
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Top companies in DRS

Company510(k)sRecalls
ICU Medical, Inc.0198
Smiths Medical Asd, Inc.218
Edwards Lifesciences, LLC37
Argon Medical Devices, Inc09
Medex, Inc.70
Sorensen Research70
Gould, Inc.60
Transamerica Delaval, Inc.60
Hewlett-Packard Co.50
Bentley Laboratories, Inc.40
Decided510(k)Device and applicantCode
Sep 10, 2026K254074TruPress
Procerus Enterprises
DRS
Mar 21, 2025K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
Edwards Lifesciences, LLC
DRS
Mar 17, 2023K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
Merit Medical Pte. , Ltd., SG
DRS
Nov 9, 2017K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with
Smiths Medical Asd, Inc.
DRS
May 24, 2017K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with
Smiths Medical Asd, Inc.
DRS
Nov 22, 2016K161408Compass Cast and MAP
Centurion Medical Products Corporation
DRS
Oct 31, 2016K152472Disposable Pressure Transducer
Zhejiang Haisheng Medical Device Co., Ltd., CN
DRS
Jan 19, 2016K152980Flo Trac sensor, Volume View sensor
Edwards Lifesciences, LLC
DRS
Sep 4, 2015K151040Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel bl
Biometrix , Ltd., IL
DRS
Apr 18, 2014K133624COMPASS CT, COMPASS CT PORT
Mirador Biomedical
DRS
May 8, 2013K123095MEDLINE BLOOD PRESSURE TRANSDUCER
Medline Industries, Inc.
DRS
Jun 8, 2012K120624ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
Elcam Medical Acal, IL
DRS
Dec 14, 2011K112203COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
Mirador Biomedical, Inc.
DRS
Apr 7, 2011K102033COMBITRANS MONITORING SETS AND ACCESSORIES
B.Braun Melsungen AG
DRS
Jan 20, 2011K103715COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
Mirador Biomedical, Inc.
DRS
Dec 22, 2010K101189REAVILLMED PRESSURE MONITORING SYSTEM AND PICC
Reavillmed
DRS
Oct 13, 2010K101518COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE
Mirador Biomedical, Inc.
DRS
Dec 10, 2009K092644TERUMO PRESSURE ISOLATOR
Terumo Cardiovascular Systems Corp.
DRS
Aug 18, 2009K091408DISPOSABLE PRESSURE TRANSDUCER
Shenzhen Ant Hi-Tech Industrial Co., Ltd., CN
DRS
Apr 19, 2007K070710ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
Biosensors International-USA
DRS
Sep 25, 2006K062342TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT
Sentra Medical Devices, LLC
DRS
Sep 19, 2006K061573TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
Hospira, Inc.
DRS
Feb 17, 2006K052828DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
Hospira, Inc.
DRS
Jan 26, 2005K043065VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
Edwards Lifesciences, LLC
DRS
Feb 5, 1999K983372BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP
Sunscope Intl., Inc.
DRS
Aug 20, 1998K981747BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
Sunscope Intl., Inc.
DRS
Jul 17, 1998K981745BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX
Sunscope Intl., Inc.
DRS
Jun 27, 1996K961404MX960 REUSABLE PRESSURE TRANSDUCER
Medex, Inc.
DRS
Mar 25, 1996K951722PERCEPTOR COMPENSATOR MORSE MANIFOLD
Namic
DRS
Apr 5, 1995K951129NOVATRANS II
Medex, Inc.
DRS
Jul 21, 1993K930888WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM
Ralin Medical, Inc.
DRS
Jan 5, 1993K921343COBE PATIENT MONITORING PRODUCTS
Cobe Cardiovascular, Inc.
DRS
Dec 11, 1992K920977MERITRANS(TM) DISPOSABLE TRANSDUCER
Merit Medical Systems, Inc.
DRS
Nov 2, 1992K921898TAD MODEL #9655
Loric Technology
DRS
Apr 22, 1991K910764THE PERCEPTOR(TM) STAND ALONE TRANSDUCER
North American Instrument Corp.
DRS
Jan 15, 1991K904777SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS
Baxter Healthcare Corp
DRS
Dec 17, 1990K904601ADVANCE DISPOSABLE PRESSURE TRANSDUCER
Advance Medical Designs, Inc.
DRS
Aug 23, 1990K902472MORSE DT MANIFOLD
North American Instrument Corp.
DRS
Aug 23, 1990K902453OSCILLOMETRIC PULSE DETECTION DEVICE
Thomas J. Fogarty, M.D.
DRS
May 9, 1990K900551MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.
Matrix Medica, Inc.
DRS
Mar 6, 1990K884235COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT
Burron Medical, Inc.
DRS
Jan 25, 1989K885296MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F
Baxter Healthcare Corp
DRS
Jan 5, 1989K884919DISPOSABLE DOME STOCK #D-300
Advanced Medical, Inc.
DRS
Sep 16, 1988K881297BARO-GRAF 24
Instromedix, Inc.
DRS
Sep 12, 1988K883095MX860, REUSABLE PRESSURE TRANSDUCER
Medex, Inc.
DRS
Aug 2, 1988K882118MODEL 700 PATIENT MONITOR
Ivy Biomedical Systems, Inc.
DRS
Jan 12, 1988K873168SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS
Spectramed, Inc.
DRS
Sep 30, 1987K872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
American Edwards Laboratories
DRS
Jun 12, 1987K871371DIGITAL SPHYGMOMANOMETER
Omron Tateisi Electronics Co., JP
DRS
Jun 12, 1987K870356TATCH-IT
Reunion Medical Co.
DRS

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