Atlas FDA

DRS

148 FDA 510(k) clearances · Product code

77 daysmedian time to decision
259 days90th percentile
148clearances measured

FDA profile

Official device name
Transducer, Blood-Pressure, Extravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2850
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 93 · 2022: 95 · 2023: 147 · 2024: 205 · 2025: 191 · 2026: 102
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909)Edwards Lifesciences, LLC2025-03-21
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (K221782)Merit Medical Pte. , Ltd.2023-03-17
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit (K172458)Smiths Medical Asd, Inc.2017-11-09
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit (K163172)Smiths Medical Asd, Inc.2017-05-24
Compass Cast and MAP (K161408)Centurion Medical Products Corporation2016-11-22
Disposable Pressure Transducer (K152472)Zhejiang Haisheng Medical Device Co., Ltd.2016-10-31
Flo Trac sensor, Volume View sensor (K152980)Edwards Lifesciences, LLC2016-01-19
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 (K151040)Biometrix , Ltd.2015-09-04
COMPASS CT, COMPASS CT PORT (K133624)Mirador Biomedical2014-04-18
MEDLINE BLOOD PRESSURE TRANSDUCER (K123095)Medline Industries, Inc.2013-05-08
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) (K120624)Elcam Medical Acal2012-06-08
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST (K112203)Mirador Biomedical, Inc.2011-12-14
COMBITRANS MONITORING SETS AND ACCESSORIES (K102033)B.Braun Melsungen AG2011-04-07
COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE (K103715)Mirador Biomedical, Inc.2011-01-20
REAVILLMED PRESSURE MONITORING SYSTEM AND PICC (K101189)Reavillmed2010-12-22
COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE (K101518)Mirador Biomedical, Inc.2010-10-13
TERUMO PRESSURE ISOLATOR (K092644)Terumo Cardiovascular Systems Corp.2009-12-10
DISPOSABLE PRESSURE TRANSDUCER (K091408)Shenzhen Ant Hi-Tech Industrial Co., Ltd.2009-08-18
ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM (K070710)Biosensors International-USA2007-04-19
TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT (K062342)Sentra Medical Devices, LLC2006-09-25
TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT (K061573)Hospira, Inc.2006-09-19
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) (K052828)Hospira, Inc.2006-02-17
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P (K043065)Edwards Lifesciences, LLC2005-01-26
BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP (K983372)Sunscope Intl., Inc.1999-02-05
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX (K981747)Sunscope Intl., Inc.1998-08-20
BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX (K981745)Sunscope Intl., Inc.1998-07-17
MX960 REUSABLE PRESSURE TRANSDUCER (K961404)Medex, Inc.1996-06-27
PERCEPTOR COMPENSATOR MORSE MANIFOLD (K951722)Namic1996-03-25
NOVATRANS II (K951129)Medex, Inc.1995-04-05
WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM (K930888)Ralin Medical, Inc.1993-07-21
COBE PATIENT MONITORING PRODUCTS (K921343)Cobe Cardiovascular, Inc.1993-01-05
MERITRANS(TM) DISPOSABLE TRANSDUCER (K920977)Merit Medical Systems, Inc.1992-12-11
TAD MODEL #9655 (K921898)Loric Technology1992-11-02
THE PERCEPTOR(TM) STAND ALONE TRANSDUCER (K910764)North American Instrument Corp.1991-04-22
SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS (K904777)Baxter Healthcare Corp1991-01-15
ADVANCE DISPOSABLE PRESSURE TRANSDUCER (K904601)Advance Medical Designs, Inc.1990-12-17
MORSE DT MANIFOLD (K902472)North American Instrument Corp.1990-08-23
OSCILLOMETRIC PULSE DETECTION DEVICE (K902453)Thomas J. Fogarty, M.D.1990-08-23
MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. (K900551)Matrix Medica, Inc.1990-05-09
COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT (K884235)Burron Medical, Inc.1990-03-06
MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F (K885296)Baxter Healthcare Corp1989-01-25
DISPOSABLE DOME STOCK #D-300 (K884919)Advanced Medical, Inc.1989-01-05
BARO-GRAF 24 (K881297)Instromedix, Inc.1988-09-16
MX860, REUSABLE PRESSURE TRANSDUCER (K883095)Medex, Inc.1988-09-12
MODEL 700 PATIENT MONITOR (K882118)Ivy Biomedical Systems, Inc.1988-08-02
SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS (K873168)Spectramed, Inc.1988-01-12
TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 (K872596)American Edwards Laboratories1987-09-30
TATCH-IT (K870356)Reunion Medical Co.1987-06-12
DIGITAL SPHYGMOMANOMETER (K871371)Omron Tateisi Electronics Co.1987-06-12
MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER (K870301)Medex, Inc.1987-05-06
SHELF LIFE CHANGE OF STERILE DEVICES (K864090)Utah Medical Products, Inc.1987-03-20
GOULD XCALIBER (K862344)Bio-Tek Instruments, Inc.1986-08-06
DISPOSABLE FLUSH DEVICE (K860681)Hewlett-Packard Co.1986-06-17
TDK ECG ELECTRODE MEL-08-09 & -11 (K854596)Tdk Corp.1986-05-07
DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE (K853996)Transamerica Delaval, Inc.1986-05-07
MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR (K855145)Gould, Inc.1986-02-26
CARDIMAX FX-406U (K854505)Brentwood Instruments, Inc.1986-02-04
OMNIGRAPH 4000(ELECTROCARDIOGRAPH) (K852652)Telemed Div.1985-11-19
CARDIO METRICS INVASIVE PRESSURE MONIT (K841960)Sterile Design, Inc.1985-11-08
GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX (K851486)Gould, Inc.1985-10-17
BENTLEY-TRANTEC DISPOS. DOMES D-260- (K841811)American Bentley1985-09-09
DOME, DISPOSABLE, STERILE (K851989)Transamerica Delaval, Inc.1985-08-19
ADMINISTRATION SET (K851988)Transamerica Delaval, Inc.1985-08-16
FLUSH DEVICE, AUTOMATIC (K851987)Transamerica Delaval, Inc.1985-08-16
APM DISPOS. BLOOD PRESSURE TRANSDUCER (K851888)Honeywell, Inc.1985-08-06
MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER (K850898)Medi-Trace Products Division1985-07-25
DISPOS. PRESSURE KIT 1295K SERIES (K843273)Hewlett-Packard Co.1985-06-11
MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO (K843580)Graphic Controls Corp.1985-05-28
PRESSURE MONITORING KIT (K842352)Utah Medical Products, Inc.1985-03-25
UTAH DISPOSABLE PRESSURE TRANSDUCER (K841788)Utah Medical Products, Inc.1985-03-25
PRESSURE TRANSDUCER DOME 1295C (K841613)Hewlett-Packard Co.1984-10-24
MONITORING KIT (K833171)Transamerica Delaval, Inc.1984-09-06
FLUSH DEVICE (K833170)Transamerica Delaval, Inc.1984-08-12
DESERET DISPOSABLE PRESSURE TRANSDUCER (K841968)Parke-Davis Co.1984-08-06
TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC (K840023)American Bentley1984-06-22
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C (K840121)Hewlett-Packard Co.1984-05-16
CARDIOFAX ECG 6543 (K840274)Nihon Kohden America, Inc.1984-04-17
MODEL TTPM TIME TEMP. PRESSURE MONITOR (K832897)Electromedics, Inc.1984-03-22
TRANTECSILICONE QUARTZ DISP. TRANSD (K833792)American Bentley1984-02-10
INVASIVE MONITORING KITS (K832907)American Pharmaseal Div. Ahsc1984-01-10
NAMIC CONTINUOUS FLUSH DEVICE (K833271)North American Instrument Corp.1983-12-01
DISPOSABLE MANIFOLD SET (K832657)Mallinckrodt Critical Care1983-11-07
TRANSDUCER DOME SD105 (K833095)Sorensen Research1983-11-03
TRANSDUCER DOME DS106 (K833096)Sorensen Research1983-11-03
TRANSDUCER DOME SD104 (K833094)Sorensen Research1983-11-03
DISP. TRANSDUCER W/MONITORING KIT TRANS (K831506)Sorensen Research1983-08-12
PRESSURE MONITORING IV BOTTLE CAP (K831867)Alto Development Corp.1983-08-12
DISPOSABLE PRESSURE TRANSDUCER#14004195 (K831698)Norton Performance Plastics Corp.1983-08-11
FLUID ADMIN. SET AFS-1C (K831348)Linton Biomed Corp.1983-05-27
DISPOSABLE PRESSURE TRANSDUCER (K830210)American Pharmaseal Div. Ahsc1983-04-18
PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630 (K823334)Psitron1983-03-24
USCI ELECTRONIC MANOMETER (K830093)C.R. Bard, Inc.1983-01-28
MODELS DPT 1000/DPT 1000NS (K823286)Bio-Med Corp.1982-12-30
DISPOSABLE TRANSDUCER & ACCESSORIES (K822507)Gould, Inc.1982-09-14
DISPOSABLE TRANSDUCER DOMES & KITS (K821894)American Pharmaseal Div. Ahsc1982-07-20
DISPOSABLE BLOOD PRESSURE TRANSDUCER (K821416)Bentley Laboratories, Inc.1982-07-02
VIRAGARD/VIRASHIELD (K820459)Tri-Med, Inc.1982-06-16
PRESSURE TUBING-ADULT & PEDIATRIC (K821450)Gould, Inc.1982-05-25
FLEX-E1 ECG ELECTRODE (K820579)Conmedcorp1982-04-14
TOUCH FLUSH CONTINUOUS FAST/FLUSH (K820677)Norton Performance Plastics Corp.1982-03-25
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Every clearance here is in the API, with alerts when new ones post.