Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DXO — Predicate Candidate Screening
64 FDA 510(k) clearances under this product code; the 50 most recent screened below.
106 daysmedian FDA review time
262 days90th percentile
64clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251367 | OptoMonitor 3 | Opsens, Inc. | 2026-01-16 | 260 | 0 |
| K241418 | OptoMonitor 3 | Opsens, Inc. | 2025-02-12 | 268 | 0 |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. | 2024-07-17 | 219 | 0 |
| K222216 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2022-12-22 | 150 | 0 |
| K202943 | OptoMonitor 3 | Opsens, Inc. | 2020-11-24 | 55 | 0 |
| K193620 | OptoMonitor 3 | Opsens, Inc. | 2020-06-18 | 175 | 0 |
| K193279 | Comet II Pressure Guidewire | Boston Scientific Corporation | 2019-12-23 | 26 | 0 |
| K192340 | OptoMonitor | Opsens, Inc. | 2019-12-12 | 106 | 0 |
| K190852 | Zurich Pressure Guidewire System Model 100 | Zurich Medical, Inc. | 2019-08-14 | 134 | 0 |
| K183413 | TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC | 2019-05-01 | 142 | 2 |
| K180558 | PressureWire X | St. Jude Medical (Now Part of Abbott Medical) | 2018-03-28 | 27 | 0 |
| K171996 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2017-10-23 | 112 | 1 |
| K163376 | Mikro-Cath Pressure Catheter | Millar, Inc. | 2017-03-10 | 99 | 0 |
| K161263 | OptoMonitor II | Opsens, Inc. | 2016-09-13 | 131 | 0 |
| K161171 | PressureWire X Guidewire | St. Jude Medical, Inc. | 2016-08-15 | 111 | 0 |
| K151610 | Comet Pressure Guidewire | Boston Scientific Corporation | 2015-10-06 | 113 | 0 |
| K142749 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2015-01-18 | 116 | 3 |
| K140466 | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS A | St. Jude Medical Systems AB | 2014-11-13 | 262 | 0 |
| K141495 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | Edwards Lifesciences, LLC | 2014-09-03 | 89 | 0 |
| K132474 | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CAT | Acist Medical Systems | 2014-01-30 | 176 | 0 |
| K131452 | PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 | St. Jude Medical Systems AB | 2013-09-05 | 108 | 0 |
| K113584 | PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEI | St Jude Medical | 2012-03-02 | 88 | 0 |
| K112323 | CARDIA-CATH | Millar Instruments, Inc. | 2011-10-18 | 67 | 0 |
| K093111 | MIKRO-CATH, MODEL 825-0101 | Millar Instruments, Inc. | 2010-01-05 | 96 | 0 |
| K080813 | PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), R | Radi Medical Systems AB | 2008-07-01 | 102 | 0 |
| K070487 | SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX | Volcano Corporation | 2007-03-16 | 24 | 0 |
| K062769 | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 | Radi Medical Systems AB | 2006-12-04 | 80 | 0 |
| K053016 | WIRELESS PHYSIOLOGIC MONITORING SYSTEM | Edwards Lifesciences, LLC | 2005-12-30 | 65 | 0 |
| K031662 | PRESSURE WIRE SENSOR, MODELS 12004/12304 | Radi Medical Systems AB | 2003-06-06 | 9 | 0 |
| K022187 | PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 | Radi Medical Systems AB | 2002-09-24 | 81 | 0 |
| K935166 | FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER | Millar Instruments, Inc. | 1994-08-05 | 282 | 0 |
| K941283 | INNERSENSE DISPOSABLE MICROTRANSDUCER | Becton Dickinson Vascular Access, Inc. | 1994-04-19 | 33 | 0 |
| K925638 | PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 | Baxter Healthcare Corp | 1993-10-18 | 343 | 1 |
| K924737 | INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER | Becton Dickinson Vascular Access, Inc. | 1993-08-23 | 335 | 0 |
| K920580 | TRANSDUCER, PRESSURE, CATHETER TIP | Medamicus, Inc. | 1993-01-07 | 332 | 0 |
| K913042 | MODIFICATIONS TO SERIES OF CARDIAC CATHETERS | Sentron, Inc. | 1992-10-21 | 484 | 0 |
| K915775 | MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN | Millar Instruments, Inc. | 1992-04-20 | 118 | 0 |
| K910429 | SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER | Baxter Healthcare Corp | 1991-07-11 | 160 | 0 |
| K895721 | MILLAR MIKRO-TIP PULSE TRANSDUCER | Millar Instruments, Inc. | 1989-12-07 | 73 | 0 |
| K894033 | DISPOSABLE CATHETER PRESSURE TRANSDUCER | Deseret Medical, Inc. | 1989-10-17 | 133 | 0 |
| K894286 | PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER | Ppg Industries, Inc. | 1989-10-12 | 111 | 0 |
| K894747 | PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. | Endosonics Corp. | 1989-10-12 | 78 | 0 |
| K890492 | PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH. | Endosonics Corp. | 1989-03-02 | 30 | 0 |
| K883202 | ULTRASONIC IMAGING CATHETER | Boston Scientific Corp | 1988-11-23 | 118 | 0 |
| K883436 | PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER | Ppg Industries, Inc. | 1988-10-17 | 63 | 0 |
| K880830 | SENTORR ARTERIAL PRESSURE SENSOR | Ohmeda Medical | 1988-08-12 | 164 | 0 |
| K882031 | VITALERT 2000 VITAL SIGNS MONITOR | Draeger Medical, Inc. | 1988-07-28 | 73 | 0 |
| K874165 | DISPOSABLE CATHETER PRESSURE TRANSDUCER | Deseret Medical, Inc. | 1988-06-09 | 240 | 0 |
| K872291 | ESCORT PORTABLE PATIENT MONITOR | Medical Data Electronics | 1987-09-25 | 101 | 0 |
| K863969 | CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D | Camino Laboratories, Inc. | 1987-05-27 | 225 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda