Atlas FDA

DXO

64 FDA 510(k) clearances · Product code

106 daysmedian time to decision
262 days90th percentile
64clearances measured

FDA profile

Official device name
Transducer, Pressure, Catheter Tip
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2870
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 116 · 2022: 144 · 2023: 194 · 2024: 197 · 2025: 183 · 2026: 147
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
OptoMonitor 3 (K251367)Opsens, Inc.2026-01-16
OptoMonitor 3 (K241418)Opsens, Inc.2025-02-12
ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (K233904)Acist Medical Systems, Inc.2024-07-17
TruWave Disposable Pressure Transducer (K222216)Edwards Lifesciences, LLC2022-12-22
OptoMonitor 3 (K202943)Opsens, Inc.2020-11-24
OptoMonitor 3 (K193620)Opsens, Inc.2020-06-18
Comet II Pressure Guidewire (K193279)Boston Scientific Corporation2019-12-23
OptoMonitor (K192340)Opsens, Inc.2019-12-12
Zurich Pressure Guidewire System Model 100 (K190852)Zurich Medical, Inc.2019-08-14
TruWave Disposable Pressure Transducer (K183413)Edwards Lifeciences, LLC2019-05-01
PressureWire X (K180558)St. Jude Medical (Now Part of Abbott Medical)2018-03-28
TruWave Disposable Pressure Transducer (K171996)Edwards Lifesciences, LLC2017-10-23
Mikro-Cath Pressure Catheter (K163376)Millar, Inc.2017-03-10
OptoMonitor II (K161263)Opsens, Inc.2016-09-13
PressureWire X Guidewire (K161171)St. Jude Medical, Inc.2016-08-15
Comet Pressure Guidewire (K151610)Boston Scientific Corporation2015-10-06
TruWave Disposable Pressure Transducer (K142749)Edwards Lifesciences, LLC2015-01-18
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 (K140466)St. Jude Medical Systems AB2014-11-13
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER (K141495)Edwards Lifesciences, LLC2014-09-03
CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER (K132474)Acist Medical Systems2014-01-30
PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 (K131452)St. Jude Medical Systems AB2013-09-05
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER (K113584)St Jude Medical2012-03-02
CARDIA-CATH (K112323)Millar Instruments, Inc.2011-10-18
MIKRO-CATH, MODEL 825-0101 (K093111)Millar Instruments, Inc.2010-01-05
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER (K080813)Radi Medical Systems AB2008-07-01
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX (K070487)Volcano Corporation2007-03-16
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 (K062769)Radi Medical Systems AB2006-12-04
WIRELESS PHYSIOLOGIC MONITORING SYSTEM (K053016)Edwards Lifesciences, LLC2005-12-30
PRESSURE WIRE SENSOR, MODELS 12004/12304 (K031662)Radi Medical Systems AB2003-06-06
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 (K022187)Radi Medical Systems AB2002-09-24
FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER (K935166)Millar Instruments, Inc.1994-08-05
INNERSENSE DISPOSABLE MICROTRANSDUCER (K941283)Becton Dickinson Vascular Access, Inc.1994-04-19
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 (K925638)Baxter Healthcare Corp1993-10-18
INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER (K924737)Becton Dickinson Vascular Access, Inc.1993-08-23
TRANSDUCER, PRESSURE, CATHETER TIP (K920580)Medamicus, Inc.1993-01-07
MODIFICATIONS TO SERIES OF CARDIAC CATHETERS (K913042)Sentron, Inc.1992-10-21
MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN (K915775)Millar Instruments, Inc.1992-04-20
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER (K910429)Baxter Healthcare Corp1991-07-11
MILLAR MIKRO-TIP PULSE TRANSDUCER (K895721)Millar Instruments, Inc.1989-12-07
DISPOSABLE CATHETER PRESSURE TRANSDUCER (K894033)Deseret Medical, Inc.1989-10-17
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER (K894286)Ppg Industries, Inc.1989-10-12
PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. (K894747)Endosonics Corp.1989-10-12
PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH. (K890492)Endosonics Corp.1989-03-02
ULTRASONIC IMAGING CATHETER (K883202)Boston Scientific Corp1988-11-23
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER (K883436)Ppg Industries, Inc.1988-10-17
SENTORR ARTERIAL PRESSURE SENSOR (K880830)Ohmeda Medical1988-08-12
VITALERT 2000 VITAL SIGNS MONITOR (K882031)Draeger Medical, Inc.1988-07-28
DISPOSABLE CATHETER PRESSURE TRANSDUCER (K874165)Deseret Medical, Inc.1988-06-09
ESCORT PORTABLE PATIENT MONITOR (K872291)Medical Data Electronics1987-09-25
CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D (K863969)Camino Laboratories, Inc.1987-05-27
FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 (K864000)Fiberoptic Sensor Technlogies, Inc.1987-01-16
NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH (K860526)Nova Medical Specialties1986-05-02
MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER (K843969)Gould, Inc.1985-01-23
VSM R1 (K842213)Physio-Control Corp.1984-10-26
TRANSDUCER-MONITOR INTERFACING (K842150)Millar Instruments, Inc.1984-10-26
MODEL 110-5 & 140-8 (K842005)Camino Laboratories, Inc.1984-08-03
MINATURE PRESSURE TRANSDUCER (K834040)Carbomedics, Inc.1984-02-10
BP TRANSDUCER HOLDERS TH-2,3 & 4 (K832384)American Bentley1983-11-14
PHYSIOLOGICAL PRESSURE MEASUREMENT CATH (K832604)Camino Laboratories, Inc.1983-10-20
PHYSIOLOGICAL PRESS. MEASUREMENT CATH (K832579)Camino Laboratories, Inc.1983-10-20
PHYSIOLOGICAL PRESSURE MEASUREMENT SYS (K830638)Camino Laboratories, Inc.1983-04-18
MMI/GAELTEC CATHETER TIP TRANSDUC (K801756)Medical Measurements, Inc.1980-08-20
MILLAR MIKRO-TIP CATHETER TRANSDUCER (K792177)Millar Instruments, Inc.1979-11-15
DIGITAL BPM (K790036)Narco Air-Shields1979-03-02

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