DXO · Class II · 21 CFR 870.2870

FDA Product Code DXO: Transducer, Pressure, Catheter Tip

Leading manufacturers include Opsens, Inc., Baxter Healthcare Corp and Boston Scientific Corporation.

64
Total
64
Cleared
127d
Avg days
1979
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 249d recently vs 121d 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 Oct 06, 2015
Comet Pressure Guidewire
K151610
Boston Scientific Corporation
Cardiovascular · 113d
Cleared Oct 18, 1993
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
K925638
Baxter Healthcare Corp
Cardiovascular · 343d
Cleared Jul 11, 1991
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
K910429
Baxter Healthcare Corp
Cardiovascular · 160d
Cleared Nov 23, 1988
ULTRASONIC IMAGING CATHETER
K883202
Boston Scientific Corp
Cardiovascular · 118d

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 increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DXO Product Code

Recent submissions under DXO have taken an average of 249 days to reach a decision - up from 121 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 →