FDA Product Code DRS: Transducer, Blood-pressure, Extravascular
Leading manufacturers include Medex, Inc., Sorensen Research and Gould, Inc..
148
Total
148
Cleared
103d
Avg days
1977
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
178d
recently vs 102d historically
FDA 510(k) Cleared Transducer, Blood-pressure, Extravascular Devices (Product Code DRS)
148 devices
Cleared
Mar 21, 2025
FloTrac sensors
Edwards Lifesciences, LLC
Cardiovascular
178d
Cleared
Mar 17, 2023
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
Merit Medical Pte. , Ltd.
Cardiovascular
269d
Cleared
Nov 09, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
Smiths Medical Asd, Inc.
Cardiovascular
87d
Cleared
May 24, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
Smiths Medical Asd, Inc.
Cardiovascular
191d
Cleared
Nov 22, 2016
Compass Cast and MAP
Centurion Medical Products Corporation
Cardiovascular
186d
Cleared
Oct 31, 2016
Disposable Pressure Transducer
Zhejiang Haisheng Medical Device Co., Ltd.
Cardiovascular
427d
Cleared
Jan 19, 2016
Flo Trac sensor, Volume View sensor
Edwards Lifesciences, LLC
Cardiovascular
102d
Cleared
Sep 04, 2015
Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
Biometrix , Ltd.
Cardiovascular
137d
Cleared
Apr 18, 2014
COMPASS CT, COMPASS CT PORT
Mirador Biomedical
Cardiovascular
143d
Cleared
May 08, 2013
MEDLINE BLOOD PRESSURE TRANSDUCER
Medline Industries, Inc.
Cardiovascular
218d
Cleared
Jun 08, 2012
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
Elcam Medical Acal
Cardiovascular
99d
Cleared
Dec 14, 2011
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
Mirador Biomedical, Inc.
Cardiovascular
135d
Cleared
Jan 20, 2011
COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
Mirador Biomedical, Inc.
Cardiovascular
30d
Cleared
Dec 10, 2009
TERUMO PRESSURE ISOLATOR
Terumo Cardiovascular Systems Corp.
Cardiovascular
105d
Cleared
Sep 19, 2006
TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
Hospira, Inc.
Cardiovascular
104d
Cleared
Feb 17, 2006
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
Hospira, Inc.
Cardiovascular
135d
Cleared
Jan 26, 2005
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
Edwards Lifesciences, LLC
Cardiovascular
82d
Cleared
Feb 05, 1999
BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP
Sunscope Intl., Inc.
Cardiovascular
134d
Cleared
Aug 20, 1998
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
Sunscope Intl., Inc.
Cardiovascular
94d
Cleared
Jul 17, 1998
BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX
Sunscope Intl., Inc.
Cardiovascular
60d
Cleared
Jun 27, 1996
MX960 REUSABLE PRESSURE TRANSDUCER
Medex, Inc.
Cardiovascular
77d
Cleared
Mar 25, 1996
PERCEPTOR COMPENSATOR MORSE MANIFOLD
Namic
Cardiovascular
346d
Cleared
Apr 05, 1995
NOVATRANS II
Medex, Inc.
Cardiovascular
23d
Cleared
Jan 05, 1993
COBE PATIENT MONITORING PRODUCTS
Cobe Cardiovascular, Inc.
Cardiovascular
292d
About Product Code DRS - Regulatory Context
510(k) Submission Activity
148 total 510(k) submissions under product code DRS since 1977, with 148 receiving FDA clearance (average review time: 103 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - DRS Product Code
Recent submissions under DRS have taken an average of 178 days to reach a decision - up from 102 days historically. Manufacturers should account for longer review timelines in current project planning.
DRS devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →