Product Code: DXO FDA class 2 21 CFR 870.2870

Transducer, Pressure, Catheter Tip

Cardiovascular

The Catheter Tip Pressure Transducer is a cardiovascular device that incorporates a miniature pressure sensor at the tip of a catheter to measure intravascular or intracardiac pressures directly within the body. It is classified as FDA Class 2, indicating moderate risk, and must obtain 510(k) clearance before marketing. The product code is DXO and the applicable regulation is 21 CFR 870.2870, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DXO
Device Class: FDA class 2
Regulation Number: 870.2870
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 64 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251367	OptoMonitor 3	Jan 16, 2026	Substantially Equivalent	Opsens, Inc.
K241418	OptoMonitor 3	Feb 12, 2025	Substantially Equivalent	Opsens, Inc.
K233904	ACIST RXi System (016616); ACIST Navvus II Catheter (016675_	Jul 17, 2024	Substantially Equivalent	Acist Medical Systems, Inc.
K222216	TruWave Disposable Pressure Transducer	Dec 22, 2022	Substantially Equivalent	Edwards Lifesciences, LLC
K202943	OptoMonitor 3	Nov 24, 2020	Substantially Equivalent	Opsens, Inc.
K193620	OptoMonitor 3	Jun 18, 2020	Substantially Equivalent	Opsens, Inc.
K193279	Comet II Pressure Guidewire	Dec 23, 2019	Substantially Equivalent	Boston Scientific Corporation
K192340	OptoMonitor	Dec 12, 2019	Substantially Equivalent	Opsens, Inc.
K190852	Zurich Pressure Guidewire System Model 100	Aug 14, 2019	Substantially Equivalent	Zurich Medical, Inc.
K183413	TruWave Disposable Pressure Transducer	May 01, 2019	Substantially Equivalent	Edwards Lifeciences, LLC
K180558	PressureWire X	Mar 28, 2018	Substantially Equivalent	St. Jude Medical (Now Part of Abbott Medical)
K171996	TruWave Disposable Pressure Transducer	Oct 23, 2017	Substantially Equivalent	Edwards Lifesciences, LLC
K163376	Mikro-Cath Pressure Catheter	Mar 10, 2017	Substantially Equivalent	Millar, Inc.
K161263	OptoMonitor II	Sep 13, 2016	Substantially Equivalent	Opsens, Inc.
K161171	PressureWire X Guidewire	Aug 15, 2016	Substantially Equivalent	St. Jude Medical, Inc.
K151610	Comet Pressure Guidewire	Oct 06, 2015	Substantially Equivalent	Boston Scientific Corporation
K142749	TruWave Disposable Pressure Transducer	Jan 18, 2015	Substantially Equivalent	Edwards Lifesciences, LLC
K140466	PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300	Nov 13, 2014	Substantially Equivalent	St. Jude Medical Systems AB
K141495	TRUWAVE DISPOSABLE PRESSURE TRANSDUCER	Sep 03, 2014	Substantially Equivalent	Edwards Lifesciences, LLC
K132474	CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER	Jan 30, 2014	Substantially Equivalent	Acist Medical Systems
K131452	PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300	Sep 05, 2013	Substantially Equivalent	St. Jude Medical Systems AB
K113584	PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER	Mar 02, 2012	Substantially Equivalent	St Jude Medical
K112323	CARDIA-CATH	Oct 18, 2011	Substantially Equivalent	Millar Instruments, Inc.
K093111	MIKRO-CATH, MODEL 825-0101	Jan 05, 2010	Substantially Equivalent	Millar Instruments, Inc.
K080813	PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER	Jul 01, 2008	Substantially Equivalent	Radi Medical Systems AB
K070487	SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX	Mar 16, 2007	Substantially Equivalent	Volcano Corporation
K062769	PRESSUREWIRE CERTUS, MODELS 12006 AND 12306	Dec 04, 2006	Substantially Equivalent	Radi Medical Systems AB
K053016	WIRELESS PHYSIOLOGIC MONITORING SYSTEM	Dec 30, 2005	Substantially Equivalent	Edwards Lifesciences, LLC
K031662	PRESSURE WIRE SENSOR, MODELS 12004/12304	Jun 06, 2003	Substantially Equivalent	Radi Medical Systems AB
K022187	PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304	Sep 24, 2002	Substantially Equivalent	Radi Medical Systems AB
K935166	FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER	Aug 05, 1994	Substantially Equivalent	Millar Instruments, Inc.
K941283	INNERSENSE DISPOSABLE MICROTRANSDUCER	Apr 19, 1994	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.
K925638	PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600	Oct 18, 1993	Substantially Equivalent	Baxter Healthcare Corp
K924737	INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER	Aug 23, 1993	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.
K920580	TRANSDUCER, PRESSURE, CATHETER TIP	Jan 07, 1993	Substantially Equivalent	Medamicus, Inc.
K913042	MODIFICATIONS TO SERIES OF CARDIAC CATHETERS	Oct 21, 1992	Substantially Equivalent	Sentron, Inc.
K915775	MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN	Apr 20, 1992	Substantially Equivalent	Millar Instruments, Inc.
K910429	SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER	Jul 11, 1991	Substantially Equivalent	Baxter Healthcare Corp
K895721	MILLAR MIKRO-TIP PULSE TRANSDUCER	Dec 07, 1989	Substantially Equivalent	Millar Instruments, Inc.
K894033	DISPOSABLE CATHETER PRESSURE TRANSDUCER	Oct 17, 1989	Substantially Equivalent	Deseret Medical, Inc.
K894747	PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.	Oct 12, 1989	Substantially Equivalent	Endosonics Corp.
K894286	PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER	Oct 12, 1989	Substantially Equivalent	Ppg Industries, Inc.
K890492	PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.	Mar 02, 1989	Substantially Equivalent	Endosonics Corp.
K883202	ULTRASONIC IMAGING CATHETER	Nov 23, 1988	Substantially Equivalent	Boston Scientific Corp
K883436	PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER	Oct 17, 1988	Substantially Equivalent	Ppg Industries, Inc.
K880830	SENTORR ARTERIAL PRESSURE SENSOR	Aug 12, 1988	Substantially Equivalent	Ohmeda Medical
K882031	VITALERT 2000 VITAL SIGNS MONITOR	Jul 28, 1988	Substantially Equivalent	Draeger Medical, Inc.
K874165	DISPOSABLE CATHETER PRESSURE TRANSDUCER	Jun 09, 1988	Substantially Equivalent	Deseret Medical, Inc.
K872291	ESCORT PORTABLE PATIENT MONITOR	Sep 25, 1987	Substantially Equivalent	Medical Data Electronics
K863969	CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D	May 27, 1987	Substantially Equivalent	Camino Laboratories, Inc.
K864000	FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00	Jan 16, 1987	Substantially Equivalent	Fiberoptic Sensor Technlogies, Inc.
K860526	NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH	May 02, 1986	Substantially Equivalent	Nova Medical Specialties
K843969	MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER	Jan 23, 1985	Substantially Equivalent	Gould, Inc.
K842213	VSM R1	Oct 26, 1984	Substantially Equivalent	Physio-Control Corp.
K842150	TRANSDUCER-MONITOR INTERFACING	Oct 26, 1984	Substantially Equivalent	Millar Instruments, Inc.
K842005	MODEL 110-5 & 140-8	Aug 03, 1984	Substantially Equivalent	Camino Laboratories, Inc.
K834040	MINATURE PRESSURE TRANSDUCER	Feb 10, 1984	Substantially Equivalent	Carbomedics, Inc.
K832384	BP TRANSDUCER HOLDERS TH-2,3 & 4	Nov 14, 1983	Substantially Equivalent	American Bentley
K832604	PHYSIOLOGICAL PRESSURE MEASUREMENT CATH	Oct 20, 1983	Substantially Equivalent	Camino Laboratories, Inc.
K832579	PHYSIOLOGICAL PRESS. MEASUREMENT CATH	Oct 20, 1983	Substantially Equivalent	Camino Laboratories, Inc.
K830638	PHYSIOLOGICAL PRESSURE MEASUREMENT SYS	Apr 18, 1983	Substantially Equivalent	Camino Laboratories, Inc.
K801756	MMI/GAELTEC CATHETER TIP TRANSDUC	Aug 20, 1980	Substantially Equivalent	Medical Measurements, Inc.
K792177	MILLAR MIKRO-TIP CATHETER TRANSDUCER	Nov 15, 1979	Substantially Equivalent	Millar Instruments, Inc.
K790036	DIGITAL BPM	Mar 02, 1979	Substantially Equivalent	Narco Air-Shields