DRS · Class II · 21 CFR 870.2850

FDA Product Code DRS: Transducer, Blood-pressure, Extravascular

Leading manufacturers include Medex, Inc., Sorensen Research and Transamerica Delaval, Inc..

149
Total
149
Cleared
104d
Avg days
1977
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 222d recently vs 102d historically

FDA 510(k) Cleared Transducer, Blood-pressure, Extravascular Devices (Product Code DRS)

149 devices
1–24 of 149
Cleared Sep 10, 2026
TruPress
K254074
Procerus Enterprises
Cardiovascular · 266d
Cleared Mar 21, 2025
FloTrac sensors
K242909
Edwards Lifesciences, LLC
Cardiovascular · 178d
Cleared Mar 17, 2023
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
K221782
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
K172458
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
K163172
Smiths Medical Asd, Inc.
Cardiovascular · 191d
Cleared Nov 22, 2016
Compass Cast and MAP
K161408
Centurion Medical Products Corporation
Cardiovascular · 186d
Cleared Oct 31, 2016
Disposable Pressure Transducer
K152472
Zhejiang Haisheng Medical Device Co., Ltd.
Cardiovascular · 427d
Cleared Jan 19, 2016
Flo Trac sensor, Volume View sensor
K152980
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
K151040
Biometrix , Ltd.
Cardiovascular · 137d
Cleared Apr 18, 2014
COMPASS CT, COMPASS CT PORT
K133624
Mirador Biomedical
Cardiovascular · 143d
Cleared May 08, 2013
MEDLINE BLOOD PRESSURE TRANSDUCER
K123095
Medline Industries, Inc.
Cardiovascular · 218d
Cleared Jun 08, 2012
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
K120624
Elcam Medical Acal
Cardiovascular · 99d
Cleared Dec 14, 2011
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
K112203
Mirador Biomedical, Inc.
Cardiovascular · 135d
Cleared Apr 07, 2011
COMBITRANS MONITORING SETS AND ACCESSORIES
K102033
B.Braun Melsungen AG
Cardiovascular · 262d
Cleared Jan 20, 2011
COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
K103715
Mirador Biomedical, Inc.
Cardiovascular · 30d
Cleared Dec 22, 2010
REAVILLMED PRESSURE MONITORING SYSTEM AND PICC
K101189
Reavillmed
Cardiovascular · 238d
Cleared Oct 13, 2010
COMPASS VASCULAR ACCESS
K101518
Mirador Biomedical, Inc.
Cardiovascular · 133d
Cleared Dec 10, 2009
TERUMO PRESSURE ISOLATOR
K092644
Terumo Cardiovascular Systems Corp.
Cardiovascular · 105d
Cleared Aug 18, 2009
DISPOSABLE PRESSURE TRANSDUCER
K091408
Shenzhen Ant Hi-Tech Industrial Co., Ltd.
Cardiovascular · 98d
Cleared Apr 19, 2007
ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
K070710
Biosensors International-USA
Cardiovascular · 36d
Cleared Sep 25, 2006
TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT
K062342
Sentra Medical Devices, LLC
Cardiovascular · 45d
Cleared Sep 19, 2006
TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
K061573
Hospira, Inc.
Cardiovascular · 104d
Cleared Feb 17, 2006
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
K052828
Hospira, Inc.
Cardiovascular · 135d
Cleared Jan 26, 2005
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
K043065
Edwards Lifesciences, LLC
Cardiovascular · 82d

About Product Code DRS - Regulatory Context

510(k) Submission Activity

149 total 510(k) submissions under product code DRS since 1977, with 149 receiving FDA clearance (average review time: 104 days).

Submission volume has increased in recent years - 2 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 - DRS Product Code

Recent submissions under DRS have taken an average of 222 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 →