DRS — Transducer, Blood-Pressure, Extravascular Class II

FDA Device Classification

Classification Details

Product Code
DRS
Device Class
Class II
Regulation Number
870.2850
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242909edwards lifesciencesFloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsMarch 21, 2025
K221782merit medical pte.Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMarch 17, 2023
K172458smiths medical asdHemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDrawNovember 9, 2017
K163172smiths medical asdHemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDrawMay 24, 2017
K161408centurion medical products corporationCompass Cast and MAPNovember 22, 2016
K152472zhejiang haisheng medical device coDisposable Pressure TransducerOctober 31, 2016
K152980edwards lifesciencesFlo Trac sensor, Volume View sensorJanuary 19, 2016
K151040biometrixArt-line Single channel blood pressure system, Art-line Double channel blood preSeptember 4, 2015
K133624mirador biomedicalCOMPASS CT, COMPASS CT PORTApril 18, 2014
K123095medline industriesMEDLINE BLOOD PRESSURE TRANSDUCERMay 8, 2013
K120624elcam medical acalELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)June 8, 2012
K112203mirador biomedicalCOMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSUDecember 14, 2011
K102033b.braun melsungenCOMBITRANS MONITORING SETS AND ACCESSORIESApril 7, 2011
K103715mirador biomedicalCOMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSUREJanuary 20, 2011
K101189reavillmedREAVILLMED PRESSURE MONITORING SYSTEM AND PICCDecember 22, 2010
K101518mirador biomedicalCOMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTUREOctober 13, 2010
K092644terumo cardiovascular systemsTERUMO PRESSURE ISOLATORDecember 10, 2009
K091408shenzhen ant hi-tech industrial coDISPOSABLE PRESSURE TRANSDUCERAugust 18, 2009
K070710biosensors international-usaACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEMApril 19, 2007
K062342sentra medical devicesTRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KITSeptember 25, 2006