DRS · Class II · 21 CFR 870.2850

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

Leading manufacturers include Medex, Inc., Sorensen Research and Hewlett-Packard Co..

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
1–24 of 148
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 Jan 19, 2016
Flo Trac sensor, Volume View sensor
K152980
Edwards Lifesciences, LLC
Cardiovascular · 102d
Cleared May 08, 2013
MEDLINE BLOOD PRESSURE TRANSDUCER
K123095
Medline Industries, Inc.
Cardiovascular · 218d
Cleared Dec 10, 2009
TERUMO PRESSURE ISOLATOR
K092644
Terumo Cardiovascular Systems Corp.
Cardiovascular · 105d
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
Cleared Jun 27, 1996
MX960 REUSABLE PRESSURE TRANSDUCER
K961404
Medex, Inc.
Cardiovascular · 77d
Cleared Apr 05, 1995
NOVATRANS II
K951129
Medex, Inc.
Cardiovascular · 23d
Cleared Jan 05, 1993
COBE PATIENT MONITORING PRODUCTS
K921343
Cobe Cardiovascular, Inc.
Cardiovascular · 292d
Cleared Dec 11, 1992
MERITRANS(TM) DISPOSABLE TRANSDUCER
K920977
Merit Medical Systems, Inc.
Cardiovascular · 284d
Cleared Jan 15, 1991
SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS
K904777
Baxter Healthcare Corp
Cardiovascular · 85d
Cleared Jan 25, 1989
MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F
K885296
Baxter Healthcare Corp
Cardiovascular · 29d
Cleared Sep 12, 1988
MX860, REUSABLE PRESSURE TRANSDUCER
K883095
Medex, Inc.
Cardiovascular · 52d
Cleared Sep 30, 1987
TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
K872596
American Edwards Laboratories
Cardiovascular · 90d
Cleared May 06, 1987
MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER
K870301
Medex, Inc.
Cardiovascular · 98d
Cleared Mar 20, 1987
SHELF LIFE CHANGE OF STERILE DEVICES
K864090
Utah Medical Products, Inc.
Cardiovascular · 178d
Cleared Aug 06, 1986
GOULD XCALIBER
K862344
Bio-Tek Instruments, Inc.
Cardiovascular · 47d
Cleared Jun 17, 1986
DISPOSABLE FLUSH DEVICE
K860681
Hewlett-Packard Co.
Cardiovascular · 112d
Cleared Sep 09, 1985
BENTLEY-TRANTEC DISPOS. DOMES D-260-
K841811
American Bentley
Cardiovascular · 496d
Cleared Aug 06, 1985
APM DISPOS. BLOOD PRESSURE TRANSDUCER
K851888
Honeywell, Inc.
Cardiovascular · 97d

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 →