DXO · Class II · 21 CFR 870.2870

FDA Product Code DXO: Transducer, Pressure, Catheter Tip

Leading manufacturers include Millar Instruments, Inc., Opsens, Inc. and Camino Laboratories, Inc..

64
Total
64
Cleared
127d
Avg days
1979
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 264d recently vs 123d historically

FDA 510(k) Cleared Transducer, Pressure, Catheter Tip Devices (Product Code DXO)

64 devices
1–24 of 64
Cleared Jan 16, 2026
OptoMonitor 3
K251367
Opsens, Inc.
Cardiovascular · 260d
Cleared Feb 12, 2025
OptoMonitor 3
K241418
Opsens, Inc.
Cardiovascular · 268d
Cleared Jul 17, 2024
ACIST RXi System (016616)
K233904
Acist Medical Systems, Inc.
Cardiovascular · 219d
Cleared Dec 22, 2022
TruWave Disposable Pressure Transducer
K222216
Edwards Lifesciences, LLC
Cardiovascular · 150d
Cleared Nov 24, 2020
OptoMonitor 3
K202943
Opsens, Inc.
Cardiovascular · 55d
Cleared Jun 18, 2020
OptoMonitor 3
K193620
Opsens, Inc.
Cardiovascular · 175d
Cleared Dec 23, 2019
Comet II Pressure Guidewire
K193279
Boston Scientific Corporation
Cardiovascular · 26d
Cleared Dec 12, 2019
OptoMonitor
K192340
Opsens, Inc.
Cardiovascular · 106d
Cleared Aug 14, 2019
Zurich Pressure Guidewire System Model 100
K190852
Zurich Medical, Inc.
Cardiovascular · 134d
Cleared May 01, 2019
TruWave Disposable Pressure Transducer
K183413
Edwards Lifeciences, LLC
Cardiovascular · 142d
Cleared Mar 28, 2018
PressureWire X
K180558
St. Jude Medical (Now Part of Abbott Medical)
Cardiovascular · 27d
Cleared Oct 23, 2017
TruWave Disposable Pressure Transducer
K171996
Edwards Lifesciences, LLC
Cardiovascular · 112d
Cleared Mar 10, 2017
Mikro-Cath Pressure Catheter
K163376
Millar, Inc.
Cardiovascular · 99d
Cleared Sep 13, 2016
OptoMonitor II
K161263
Opsens, Inc.
Cardiovascular · 131d
Cleared Aug 15, 2016
PressureWire X Guidewire
K161171
St. Jude Medical, Inc.
Cardiovascular · 111d
Cleared Oct 06, 2015
Comet Pressure Guidewire
K151610
Boston Scientific Corporation
Cardiovascular · 113d
Cleared Jan 18, 2015
TruWave Disposable Pressure Transducer
K142749
Edwards Lifesciences, LLC
Cardiovascular · 116d
Cleared Nov 13, 2014
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300
K140466
St. Jude Medical Systems AB
Cardiovascular · 262d
Cleared Sep 03, 2014
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
K141495
Edwards Lifesciences, LLC
Cardiovascular · 89d
Cleared Jan 30, 2014
CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
K132474
Acist Medical Systems
Cardiovascular · 176d
Cleared Sep 05, 2013
PRESSUREWIRE
K131452
St. Jude Medical Systems AB
Cardiovascular · 108d
Cleared Mar 02, 2012
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
K113584
St Jude Medical
Cardiovascular · 88d
Cleared Oct 18, 2011
CARDIA-CATH
K112323
Millar Instruments, Inc.
Cardiovascular · 67d
Cleared Jan 05, 2010
MIKRO-CATH, MODEL 825-0101
K093111
Millar Instruments, Inc.
Cardiovascular · 96d

About Product Code DXO - Regulatory Context

510(k) Submission Activity

64 total 510(k) submissions under product code DXO since 1979, with 64 receiving FDA clearance (average review time: 127 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - DXO Product Code

Recent submissions under DXO have taken an average of 264 days to reach a decision - up from 123 days historically. Manufacturers should account for longer review timelines in current project planning.

DXO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →