Product Code: DRS FDA class 2 21 CFR 870.2850

Transducer, Blood-Pressure, Extravascular

Cardiovascular

The Extravascular Blood-Pressure Transducer is a cardiovascular measurement device used externally to convert pressure signals transmitted via fluid-filled tubing from an intravascular catheter into electrical signals for monitoring blood pressure. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRS and it is regulated under 21 CFR 870.2850 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

148

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DRS in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DRS
Device Class: FDA class 2
Regulation Number: 870.2850
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 148 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242909	FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors	Mar 21, 2025	Substantially Equivalent	Edwards Lifesciences, LLC
K221782	Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes	Mar 17, 2023	Substantially Equivalent	Merit Medical Pte. , Ltd.
K172458	HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit	Nov 09, 2017	Substantially Equivalent	Smiths Medical Asd, Inc.
K163172	HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit	May 24, 2017	Substantially Equivalent	Smiths Medical Asd, Inc.
K161408	Compass Cast and MAP	Nov 22, 2016	Substantially Equivalent	Centurion Medical Products Corporation
K152472	Disposable Pressure Transducer	Oct 31, 2016	Substantially Equivalent	Zhejiang Haisheng Medical Device Co., Ltd.
K152980	Flo Trac sensor, Volume View sensor	Jan 19, 2016	Substantially Equivalent	Edwards Lifesciences, LLC
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	Sep 04, 2015	Substantially Equivalent	Biometrix , Ltd.
K133624	COMPASS CT, COMPASS CT PORT	Apr 18, 2014	Substantially Equivalent	Mirador Biomedical
K123095	MEDLINE BLOOD PRESSURE TRANSDUCER	May 08, 2013	Substantially Equivalent	Medline Industries, Inc.
K120624	ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)	Jun 08, 2012	Substantially Equivalent	Elcam Medical Acal
K112203	COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST	Dec 14, 2011	Substantially Equivalent	Mirador Biomedical, Inc.
K102033	COMBITRANS MONITORING SETS AND ACCESSORIES	Apr 07, 2011	Substantially Equivalent	B.Braun Melsungen AG
K103715	COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE	Jan 20, 2011	Substantially Equivalent	Mirador Biomedical, Inc.
K101189	REAVILLMED PRESSURE MONITORING SYSTEM AND PICC	Dec 22, 2010	Substantially Equivalent	Reavillmed
K101518	COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE	Oct 13, 2010	Substantially Equivalent	Mirador Biomedical, Inc.
K092644	TERUMO PRESSURE ISOLATOR	Dec 10, 2009	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K091408	DISPOSABLE PRESSURE TRANSDUCER	Aug 18, 2009	Substantially Equivalent	Shenzhen Ant Hi-Tech Industrial Co., Ltd.
K070710	ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM	Apr 19, 2007	Substantially Equivalent	Biosensors International-USA
K062342	TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT	Sep 25, 2006	Substantially Equivalent	Sentra Medical Devices, LLC
K061573	TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT	Sep 19, 2006	Substantially Equivalent	Hospira, Inc.
K052828	DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)	Feb 17, 2006	Substantially Equivalent	Hospira, Inc.
K043065	VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P	Jan 26, 2005	Substantially Equivalent	Edwards Lifesciences, LLC
K983372	BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP	Feb 05, 1999	Substantially Equivalent	Sunscope Intl., Inc.
K981747	BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX	Aug 20, 1998	Substantially Equivalent	Sunscope Intl., Inc.
K981745	BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX	Jul 17, 1998	Substantially Equivalent	Sunscope Intl., Inc.
K961404	MX960 REUSABLE PRESSURE TRANSDUCER	Jun 27, 1996	Substantially Equivalent	Medex, Inc.
K951722	PERCEPTOR COMPENSATOR MORSE MANIFOLD	Mar 25, 1996	Substantially Equivalent	Namic
K951129	NOVATRANS II	Apr 05, 1995	Substantially Equivalent	Medex, Inc.
K930888	WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM	Jul 21, 1993	Substantially Equivalent	Ralin Medical, Inc.
K921343	COBE PATIENT MONITORING PRODUCTS	Jan 05, 1993	Substantially Equivalent	Cobe Cardiovascular, Inc.
K920977	MERITRANS(TM) DISPOSABLE TRANSDUCER	Dec 11, 1992	Substantially Equivalent	Merit Medical Systems, Inc.
K921898	TAD MODEL #9655	Nov 02, 1992	Substantially Equivalent	Loric Technology
K910764	THE PERCEPTOR(TM) STAND ALONE TRANSDUCER	Apr 22, 1991	Substantially Equivalent	North American Instrument Corp.
K904777	SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS	Jan 15, 1991	Substantially Equivalent	Baxter Healthcare Corp
K904601	ADVANCE DISPOSABLE PRESSURE TRANSDUCER	Dec 17, 1990	Substantially Equivalent	Advance Medical Designs, Inc.
K902472	MORSE DT MANIFOLD	Aug 23, 1990	Substantially Equivalent	North American Instrument Corp.
K902453	OSCILLOMETRIC PULSE DETECTION DEVICE	Aug 23, 1990	Substantially Equivalent	Thomas J. Fogarty, M.D.
K900551	MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.	May 09, 1990	Substantially Equivalent	Matrix Medica, Inc.
K884235	COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT	Mar 06, 1990	Substantially Equivalent	Burron Medical, Inc.
K885296	MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F	Jan 25, 1989	Substantially Equivalent	Baxter Healthcare Corp
K884919	DISPOSABLE DOME STOCK #D-300	Jan 05, 1989	Substantially Equivalent	Advanced Medical, Inc.
K881297	BARO-GRAF 24	Sep 16, 1988	Substantially Equivalent	Instromedix, Inc.
K883095	MX860, REUSABLE PRESSURE TRANSDUCER	Sep 12, 1988	Substantially Equivalent	Medex, Inc.
K882118	MODEL 700 PATIENT MONITOR	Aug 02, 1988	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K873168	SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS	Jan 12, 1988	Substantially Equivalent	Spectramed, Inc.
K872596	TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30	Sep 30, 1987	Substantially Equivalent	American Edwards Laboratories
K871371	DIGITAL SPHYGMOMANOMETER	Jun 12, 1987	Substantially Equivalent	Omron Tateisi Electronics Co.
K870356	TATCH-IT	Jun 12, 1987	Substantially Equivalent	Reunion Medical Co.
K870301	MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER	May 06, 1987	Substantially Equivalent	Medex, Inc.
K864090	SHELF LIFE CHANGE OF STERILE DEVICES	Mar 20, 1987	Substantially Equivalent	Utah Medical Products, Inc.
K862344	GOULD XCALIBER	Aug 06, 1986	Substantially Equivalent	Bio-Tek Instruments, Inc.
K860681	DISPOSABLE FLUSH DEVICE	Jun 17, 1986	Substantially Equivalent	Hewlett-Packard Co.
K854596	TDK ECG ELECTRODE MEL-08-09 & -11	May 07, 1986	Substantially Equivalent	Tdk Corp.
K853996	DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE	May 07, 1986	Substantially Equivalent	Transamerica Delaval, Inc.
K855145	MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR	Feb 26, 1986	Substantially Equivalent	Gould, Inc.
K854505	CARDIMAX FX-406U	Feb 04, 1986	Substantially Equivalent	Brentwood Instruments, Inc.
K852652	OMNIGRAPH 4000(ELECTROCARDIOGRAPH)	Nov 19, 1985	Substantially Equivalent	Telemed Div.
K841960	CARDIO METRICS INVASIVE PRESSURE MONIT	Nov 08, 1985	Substantially Equivalent	Sterile Design, Inc.
K851486	GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX	Oct 17, 1985	Substantially Equivalent	Gould, Inc.
K841811	BENTLEY-TRANTEC DISPOS. DOMES D-260-	Sep 09, 1985	Substantially Equivalent	American Bentley
K851989	DOME, DISPOSABLE, STERILE	Aug 19, 1985	Substantially Equivalent	Transamerica Delaval, Inc.
K851988	ADMINISTRATION SET	Aug 16, 1985	Substantially Equivalent	Transamerica Delaval, Inc.
K851987	FLUSH DEVICE, AUTOMATIC	Aug 16, 1985	Substantially Equivalent	Transamerica Delaval, Inc.
K851888	APM DISPOS. BLOOD PRESSURE TRANSDUCER	Aug 06, 1985	Substantially Equivalent	Honeywell, Inc.
K850898	MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER	Jul 25, 1985	Substantially Equivalent	Medi-Trace Products Division
K843273	DISPOS. PRESSURE KIT 1295K SERIES	Jun 11, 1985	Substantially Equivalent	Hewlett-Packard Co.
K843580	MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO	May 28, 1985	Substantially Equivalent	Graphic Controls Corp.
K842352	PRESSURE MONITORING KIT	Mar 25, 1985	Substantially Equivalent	Utah Medical Products, Inc.
K841788	UTAH DISPOSABLE PRESSURE TRANSDUCER	Mar 25, 1985	Substantially Equivalent	Utah Medical Products, Inc.
K841613	PRESSURE TRANSDUCER DOME 1295C	Oct 24, 1984	Substantially Equivalent	Hewlett-Packard Co.
K833171	MONITORING KIT	Sep 06, 1984	Substantially Equivalent	Transamerica Delaval, Inc.
K833170	FLUSH DEVICE	Aug 12, 1984	Substantially Equivalent	Transamerica Delaval, Inc.
K841968	DESERET DISPOSABLE PRESSURE TRANSDUCER	Aug 06, 1984	Substantially Equivalent	Parke-Davis Co.
K840023	TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC	Jun 22, 1984	Substantially Equivalent	American Bentley
K840121	PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C	May 16, 1984	Substantially Equivalent	Hewlett-Packard Co.
K840274	CARDIOFAX ECG 6543	Apr 17, 1984	Substantially Equivalent	Nihon Kohden America, Inc.
K832897	MODEL TTPM TIME TEMP. PRESSURE MONITOR	Mar 22, 1984	Substantially Equivalent	Electromedics, Inc.
K833792	TRANTECSILICONE QUARTZ DISP. TRANSD	Feb 10, 1984	Substantially Equivalent	American Bentley
K832907	INVASIVE MONITORING KITS	Jan 10, 1984	Substantially Equivalent	American Pharmaseal Div. Ahsc
K833271	NAMIC CONTINUOUS FLUSH DEVICE	Dec 01, 1983	Substantially Equivalent	North American Instrument Corp.
K832657	DISPOSABLE MANIFOLD SET	Nov 07, 1983	Substantially Equivalent	Mallinckrodt Critical Care
K833096	TRANSDUCER DOME DS106	Nov 03, 1983	Substantially Equivalent	Sorensen Research
K833095	TRANSDUCER DOME SD105	Nov 03, 1983	Substantially Equivalent	Sorensen Research
K833094	TRANSDUCER DOME SD104	Nov 03, 1983	Substantially Equivalent	Sorensen Research
K831867	PRESSURE MONITORING IV BOTTLE CAP	Aug 12, 1983	Substantially Equivalent	Alto Development Corp.
K831506	DISP. TRANSDUCER W/MONITORING KIT TRANS	Aug 12, 1983	Substantially Equivalent	Sorensen Research
K831698	DISPOSABLE PRESSURE TRANSDUCER#14004195	Aug 11, 1983	Substantially Equivalent	Norton Performance Plastics Corp.
K831348	FLUID ADMIN. SET AFS-1C	May 27, 1983	Substantially Equivalent	Linton Biomed Corp.
K830210	DISPOSABLE PRESSURE TRANSDUCER	Apr 18, 1983	Substantially Equivalent	American Pharmaseal Div. Ahsc
K823334	PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630	Mar 24, 1983	Substantially Equivalent	Psitron
K830093	USCI ELECTRONIC MANOMETER	Jan 28, 1983	Substantially Equivalent	C.R. Bard, Inc.
K823286	MODELS DPT 1000/DPT 1000NS	Dec 30, 1982	Substantially Equivalent	Bio-Med Corp.
K822507	DISPOSABLE TRANSDUCER & ACCESSORIES	Sep 14, 1982	Substantially Equivalent	Gould, Inc.
K821894	DISPOSABLE TRANSDUCER DOMES & KITS	Jul 20, 1982	Substantially Equivalent	American Pharmaseal Div. Ahsc
K821416	DISPOSABLE BLOOD PRESSURE TRANSDUCER	Jul 02, 1982	Substantially Equivalent	Bentley Laboratories, Inc.
K820459	VIRAGARD/VIRASHIELD	Jun 16, 1982	Substantially Equivalent	Tri-Med, Inc.
K821450	PRESSURE TUBING-ADULT & PEDIATRIC	May 25, 1982	Substantially Equivalent	Gould, Inc.
K820579	FLEX-E1 ECG ELECTRODE	Apr 14, 1982	Substantially Equivalent	Conmedcorp
K820677	TOUCH FLUSH CONTINUOUS FAST/FLUSH	Mar 25, 1982	Substantially Equivalent	Norton Performance Plastics Corp.
K820676	TOUCH FLUSH W/Y TRANSDUCER CONNECTOR	Mar 25, 1982	Substantially Equivalent	Norton Performance Plastics Corp.
K820457	MEDI-TRACE PHYSIOLOGICAL PRESSURE TRANS	Mar 12, 1982	Substantially Equivalent	Graphic Controls Corp.
K820355	DISPOSABLE DIAPHRAGM DOMES	Mar 04, 1982	Substantially Equivalent	Medex, Inc.
K820342	PHYSIOLOGICAL PRESSURE TRANSDUCER #900	Mar 04, 1982	Substantially Equivalent	Bentley Laboratories, Inc.
K820202	CONTINUOUS FLUSH DEVICE/FDI	Feb 12, 1982	Substantially Equivalent	Linton Biomed Corp.
K820201	DISPOS. MONITORING SYS/LI ET AL	Feb 12, 1982	Substantially Equivalent	Linton Biomed Corp.
K820186	BARD CARDIOPULMONARY MONITORING LINES	Feb 12, 1982	Substantially Equivalent	C.R. Bard, Inc.
K820046	ANESTHESIOLOGY DEVICES	Jan 29, 1982	Substantially Equivalent	Bentley Laboratories, Inc.
K813266	NIHON KOHDEN ELECTROCARDIOGRAPH	Jan 29, 1982	Substantially Equivalent	Nihon Kohden America, Inc.
K813549	CONTINUOUS FLUSH DEVICE	Jan 12, 1982	Substantially Equivalent	Namic
K813464	DISPOSABLE TRANSDUCER	Jan 07, 1982	Substantially Equivalent	Sorensen Research
K813502	NARCO TELECARE ISOFLO PRESSURE MONITOR	Dec 29, 1981	Substantially Equivalent	Narco Bio-Systems
K813267	DISPOSABLE DIAPHRAGM DOMES	Dec 14, 1981	Substantially Equivalent	Dio-Med Corp.
K813137	CORREC TORR TM	Dec 02, 1981	Substantially Equivalent	Norton Performance Plastics Corp.
K813053	DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM	Nov 16, 1981	Substantially Equivalent	Bentley Laboratories, Inc.
K812884	NARCO TELECARE PRESSURE TRANSDUCER DOME	Nov 02, 1981	Substantially Equivalent	Narco Scientific
K812883	TELECARE ISOTEC PRESSURE TRANSDUCER DOME	Nov 02, 1981	Substantially Equivalent	Narco Scientific
K812758	PHYSIOLOGICAL PRESSURE TRANSDUCER	Oct 20, 1981	Substantially Equivalent	Electromedics, Inc.
K812530	TRANSDUCER DOME	Oct 13, 1981	Substantially Equivalent	Biomeal Corp.
K811980	ELECTRONIC BLOOD PRESSURE TRANSDUCER MAN	Jul 28, 1981	Substantially Equivalent	H.R. Biomedical, Ltd.
K811538	MODELS TA 1017 & 1017T GRITIFLO DISPOS	Jun 12, 1981	Substantially Equivalent	Gould, Inc.
K810735	DISPOSABLE, STERILE TRANSDUCER DOMES	May 08, 1981	Substantially Equivalent	Bio-Med Corp.
K810637	COBE DISPOSABLE PRESSURE TRANSDUCER	Apr 23, 1981	Substantially Equivalent	Cobe Laboratories, Inc.
K810661	CATHDAMP	Mar 27, 1981	Substantially Equivalent	Medline Industries, Inc.
K810431	NARCO TLECARE MINIATURE PRESSURE DOME	Mar 11, 1981	Substantially Equivalent	Narco Bio-Systems
K810009	DISPOSABLE DIAPHRAGM DOME	Feb 19, 1981	Substantially Equivalent	Medex, Inc.
K803096	NARCO TELECARE TRANSDUCER DOME #700-4000	Jan 13, 1981	Substantially Equivalent	Narco Scientific
K802179	CARDIOSCOPE J200	Nov 12, 1980	Substantially Equivalent	Telectronics, Inc.
K802069	DISP. TRANSDUCER DOMES TD200 & TD300	Sep 09, 1980	Substantially Equivalent	Bio-Med Corp.
K801985	BIO-MED CORP. DISP. NON-STERILE TRANSDU	Sep 09, 1980	Substantially Equivalent	Bio-Med Corp.
K801239	STERILE, DISP DOME, INDIVID. PKG.	Jul 14, 1980	Substantially Equivalent	Pacific Domes, Inc.
K801138	MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.	Jul 14, 1980	Substantially Equivalent	Gics Pharmaceuticals
K801136	D300 DOME	Jun 20, 1980	Substantially Equivalent	Gics Pharmaceuticals
K801048	ACCUDYNAMIC	May 14, 1980	Substantially Equivalent	Sorensen Research
K800706	MEDI-TRACE DISPOSABLE DOMES/MONITORING	Apr 16, 1980	Substantially Equivalent	Graphic Controls Corp.
K800705	MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO	Apr 16, 1980	Substantially Equivalent	Graphic Controls Corp.
K792020	AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCER	Dec 07, 1979	Substantially Equivalent	Life Medical Services, Inc.
K792073	MODEL 1979 BLOOD PRESSUROMETER R CHARTER	Nov 05, 1979	Substantially Equivalent	Del Mar Avionics
K791636	ACCUNAMIC	Oct 04, 1979	Substantially Equivalent	Sorensen Research
K790407	MICROTEC BACTERIAL FILTER	May 16, 1979	Substantially Equivalent	Medex, Inc.
K781680	MONITORING, PRESSURE KIT	Oct 06, 1978	Substantially Equivalent	Pharmaseal Div., Baxter Healthcare Corp.
K780797	TRANSDUCER, PRESSURE, OPTION, H-P, P23ID	Jun 13, 1978	Substantially Equivalent	Gould, Inc.
K780477	PHYSIOLOGICAL PRESSURE TRANSDUCER	Apr 13, 1978	Substantially Equivalent	Bell & Howell Instruments
K780128	BLOOD PRESSURE MONITOR, ARTERIAL	Jan 31, 1978	Substantially Equivalent	Applied Medical Research
K780127	DINAMAP MODEL 850	Jan 31, 1978	Substantially Equivalent	Applied Medical Research
K771668	DISP. FLUID ISOLATOR & PRESS. RELIEF	Sep 14, 1977	Substantially Equivalent	Ailtech
K771361	PHYSIOLOGICAL PRESSURE TRANSDUCER 1290A	Aug 04, 1977	Substantially Equivalent	Hewlett-Packard Co.
K761325	MODEL DA-53 PRESSURE GUAGE ISOLATOR	Jan 06, 1977	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.