Product Code: DPW FDA class 2 21 CFR 870.2100

Flowmeter, Blood, Cardiovascular

Cardiovascular

The Flowmeter, Blood, Cardiovascular is a diagnostic device used to measure blood flow rates in cardiovascular structures, typically employing electromagnetic or ultrasonic techniques, used intraoperatively or in research settings to assess cardiac output and vascular function. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DPW, regulated under 21 CFR 870.2100, within the Cardiovascular medical specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

137

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: DPW
Device Class: FDA class 2
Regulation Number: 870.2100
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 137 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252810	FloPatch FP120	Apr 24, 2026	Substantially Equivalent	Flosonics Medical
K251904	VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)	Nov 20, 2025	Substantially Equivalent	Remington Medical, Inc.
K251114	FloPatch FP120	Jun 20, 2025	Substantially Equivalent	Flosonics Medical
K243852	Elfor-L	Apr 14, 2025	Substantially Equivalent	Elfi-Tech , Ltd.
K241583	VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)	Aug 30, 2024	Substantially Equivalent	Remington Medical, Inc.
K223843	FloPatch FP120	May 03, 2023	Substantially Equivalent	Flosonics Medical
K222242	FloPatch FP120	Dec 09, 2022	Substantially Equivalent	Flosonics Medical
K213974	GEM FLOW COUPLER Monitor (GEM1020M-2)	Apr 20, 2022	Substantially Equivalent	Synovis Micro Companies Alliance, Inc.
K211589	VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger	Jan 27, 2022	Substantially Equivalent	Remington Medical, Inc.
K212065	VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger	Oct 07, 2021	Substantially Equivalent	Remington Medical, Inc.
K201114	Bidop 7	Jan 05, 2021	Substantially Equivalent	Koven Technology, Inc.
K200337	FloPatch (FP120)	Mar 24, 2020	Substantially Equivalent	Flosonics Medical (R/A 1929803 Ontario Corp.)
K192966	FlowMet	Jan 10, 2020	Substantially Equivalent	Laser Associated Sciences, Inc.
K183574	SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes	Sep 06, 2019	Substantially Equivalent	Huntleigh Healthcare , Ltd.
K191388	FloPatch (FP110)	Jun 21, 2019	Substantially Equivalent	Flosonics Medical (R/A 1929803 Ontario Corp.)
K182494	FlowMet-R	Feb 27, 2019	Substantially Equivalent	Laser Associated Sciences, Inc.
K181269	iCertainty	Dec 14, 2018	Substantially Equivalent	Rfpi
K172457	Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM	Jun 28, 2018	Substantially Equivalent	Deltex Medical Limited
K152930	PeriFlux6000	May 05, 2016	Substantially Equivalent	Perimed AB
K150268	CerOX	Nov 06, 2015	Substantially Equivalent	Or-Nim Medical , Ltd.
K150347	Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+	Jul 24, 2015	Substantially Equivalent	Deltex Medical Limited
K140740	TRANSONIC TISSUE PERFUSION MONITOR	Jul 23, 2015	Substantially Equivalent	Transonic Systems, Inc.
K132139	DELTEX MEDICAL CARDIOQ-EDM+	Oct 10, 2013	Substantially Equivalent	Deltex Medical Limited
K131854	CEROX	Sep 13, 2013	Substantially Equivalent	Or-Nim Medical , Ltd.
K111730	SONOTT FLOWLAB(R)	Jan 06, 2012	Substantially Equivalent	Em-Tec GmbH
K112657	AUREFLO MONITORING SYSTEM	Dec 21, 2011	Substantially Equivalent	Transonic Systems, Inc.
K111542	DELTEX MEDICAL CARDIOQ EDM	Oct 20, 2011	Substantially Equivalent	Deltex Medical Limited
K110438	SENSILASE PAD-IQ	May 04, 2011	Substantially Equivalent	Vasamed, Inc.
K110347	DOPPLER MONITOR	Mar 16, 2011	Substantially Equivalent	Cook Vascular, Inc.
K102595	MEDISTIM VERIQC SYSTEM	Dec 27, 2010	Substantially Equivalent	Medi-Stim Asa
K102433	MOORVMS-PRES PRESSURE CUFF CONTROLLER	Nov 18, 2010	Substantially Equivalent	Moor Instruments, Ltd.
K082870	VTI INTRAOPERATIVE DOPPLER SYSTEMS	Oct 28, 2008	Substantially Equivalent	Vascular Technology Incorporated
K062977	CRITIVIEW, MODEL CRV3	Feb 28, 2007	Substantially Equivalent	Critisense , Ltd.
K051145	CRITIVIEW	Jan 18, 2006	Substantially Equivalent	Critisense , Ltd.
K052209	VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01	Sep 06, 2005	Substantially Equivalent	Vascular Control Systems, Inc.
K050601	SMARTDOP 45 VASCULAR DOPPLER	Apr 15, 2005	Substantially Equivalent	Koven Technology, Inc.
K050088	QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER	Feb 08, 2005	Substantially Equivalent	Neoprobe Corp.
K041180	QUANTIX OR VESSEL STABILIZER DEVICE	Jun 07, 2004	Substantially Equivalent	Cardiosonix, Ltd.
K040654	SENSILASE PAD 3000	Jun 04, 2004	Substantially Equivalent	Optical Sensors, Inc.
K040228	MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122	Apr 29, 2004	Substantially Equivalent	Medi-Stim A/S
K040909	SONO TT ULTRASONIC FLOWCOMPUTER	Apr 20, 2004	Substantially Equivalent	Em-Tec GmbH
K031931	ECHO SOUNDER EX-101EX 8 MHZ	Feb 13, 2004	Substantially Equivalent	Koven Technology, Inc.
K033424	ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002	Dec 11, 2003	Substantially Equivalent	Transonic Systems, Inc.
K031153	MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065	Nov 25, 2003	Substantially Equivalent	Arrow Intl., Inc.
K030357	QUANTIX/OR DEVICE	Aug 20, 2003	Substantially Equivalent	Cardiosonix, Ltd.
K031706	CARDIOQ, MODEL 9051-7005	Aug 06, 2003	Substantially Equivalent	Deltex Medical
K030505	CAPIOX CARDIOTOMY RESERVOIR	May 14, 2003	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K031091	VTI 20 MHZ GATED DOPPLER	Apr 23, 2003	Substantially Equivalent	Vascular Technology Incorporated
K023431	QUANTIX/ND DEVICE	Nov 13, 2002	Substantially Equivalent	Cardiosonix, Ltd.
K013376	QFLOW 500 PERFUSION MONITORING SYSTEM	May 08, 2002	Substantially Equivalent	Hemedex Incorporated
K013803	FLOWGUARD DEVICE	Feb 13, 2002	Substantially Equivalent	Biosonix , Ltd.
K010452	BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T	Feb 12, 2002	Substantially Equivalent	Koven Technology, Inc.
K011899	PF 5050 PRESSURE UNIT, MODEL PF 5050	Nov 06, 2001	Substantially Equivalent	Perimed AB
K002186	VASCULAR ASSIST	May 02, 2001	Substantially Equivalent	Huntleigh Healthcare, Inc.
K992529	TISSUE SPECTROSCOPE	Nov 17, 2000	Substantially Equivalent	Vital Medical , Ltd.
K984338	JOSTRA HL-20 TWIN PUMP	Aug 19, 1999	Substantially Equivalent	Jostra Bentley
K992388	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200	Aug 03, 1999	Substantially Equivalent	Rossmax International , Ltd.
K992387	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100	Aug 03, 1999	Substantially Equivalent	Rossmax International , Ltd.
K973078	WRIST BLOOD PRESSURE METER MODEL SE-330	May 20, 1999	Substantially Equivalent	Sein Electronics Co., Ltd.
K982986	TUBING BLOOD FLOW METER MODEL NUMBER HD-800	Nov 24, 1998	Substantially Equivalent	Koven Technology, Inc.
K973198	VGF-7 VASCULAR GRAFT FLOWMETER	Oct 14, 1998	Substantially Equivalent	Medicard , Ltd.
K974285	PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT	May 28, 1998	Substantially Equivalent	Perimed, Inc.
K970211	MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR	Apr 30, 1998	Substantially Equivalent	Micro Weiss Electronics
K970139	MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO	Apr 30, 1998	Substantially Equivalent	Micro Weiss Electronics
K972213	MS-700	Mar 13, 1998	Substantially Equivalent	Alan S. Lee
K972798	DYNEMO 3000	Feb 24, 1998	Substantially Equivalent	Sometec, Inc.
K954397	BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY	Mar 29, 1996	Substantially Equivalent	Koven Technology, Inc.
K951369	EDM	Nov 07, 1995	Substantially Equivalent	Deltex Medical
K951486	MODEL PV2000 VASCULAR MICROLABORATORY	Jun 29, 1995	Substantially Equivalent	Vasamedics, LLC
K942613	SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR	Dec 23, 1994	Substantially Equivalent	Koven Technology, Inc.
K932068	PERITEMP PF 4005 HEATER	Dec 07, 1993	Substantially Equivalent	Perimed, Inc.
K921377	P/METER	Oct 12, 1993	Substantially Equivalent	Zertl Medical, Inc.
K930227	MS DISPOSABLE RIGID DOPPLER PROBE	Sep 16, 1993	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K925524	CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)	Aug 23, 1993	Substantially Equivalent	Cardio Metrics, Inc.
K922034	LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER	May 18, 1993	Substantially Equivalent	Titronics Medical Instruments, Inc.
K922368	PERIFLUX PF4001 LASER DOPPLER FLOWMETER	Feb 03, 1993	Substantially Equivalent	Perimed, Inc.
K922669	MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW	Jan 29, 1993	Substantially Equivalent	Koven and Assoc., Inc.
K920333	SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR	Jan 22, 1993	Substantially Equivalent	Koven and Assoc., Inc.
K915550	MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR	Dec 10, 1992	Substantially Equivalent	Koven and Assoc., Inc.
K920844	PIM 1.0 LASER DOPPLER PERFUSION IMAGER	Jul 21, 1992	Substantially Equivalent	Lisca Development AB
K912562	ABCOM 2000	Jan 09, 1992	Substantially Equivalent	Applied Biometrics, Inc.
K912446	MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2	Dec 12, 1991	Substantially Equivalent	Vasamedics, LLC
K913827	MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG	Nov 19, 1991	Substantially Equivalent	Hewlett-Packard Co.
K911763	LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)	Aug 13, 1991	Substantially Equivalent	Vasamedics, LLC
K910049	INTERSPEC APOGEE, MODIFICATION	Apr 29, 1991	Substantially Equivalent	Interspec, Inc.
K905411	FLOWIRE AND FLOMAP	Mar 29, 1991	Substantially Equivalent	Cardio Metrics, Inc.
K903026	ES-1000SP II SMART DOP	Feb 26, 1991	Substantially Equivalent	Koven and Assoc., Inc.
K904317	AVALON GENERAL PURPOSE SCANNER, PREVIEW GP	Feb 13, 1991	Substantially Equivalent	Avalon Technology Corp.
K904792	DIAGNOSTIC ULTRASOUND VERSADOPP 1000	Jan 28, 1991	Substantially Equivalent	Diagnostic Ultrasound Corp.
K903625	DOPPLER NEEDLE AND FLOW MONITOR	Nov 07, 1990	Substantially Equivalent	Peripheral Systems Group
K901015	WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC	Nov 05, 1990	Substantially Equivalent	Wright Medical Corp.
K903633	ADVANCE LASER FLOWMETER, ALF 21	Oct 09, 1990	Substantially Equivalent	Transonic Systems, Inc.
K901335	ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER	Aug 10, 1990	Substantially Equivalent	Ge Medical Systems Information Technologies
K902088	MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND	Aug 08, 1990	Substantially Equivalent	Hewlett-Packard Co.
K901733	MODIFIED FLOCATH PULMONARY ARTERY CATHETER	Jul 16, 1990	Substantially Equivalent	Cardio Metrics, Inc.
K896613	FLAT VASCULAR PROBE	Feb 16, 1990	Substantially Equivalent	Imex Medical Systems, Inc.
K896515	LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2	Feb 13, 1990	Substantially Equivalent	Tsi, Inc.
K894631	NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.	Jan 19, 1990	Substantially Equivalent	Nihon Kohden America, Inc.
K892707	DVM-4200 BLOOD FLOWMETER	Jul 28, 1989	Substantially Equivalent	Koven and Assoc., Inc.
K890828	PERIFLUX PF3	Jun 20, 1989	Substantially Equivalent	Perimed, Inc.
K882138	IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER	Nov 07, 1988	Substantially Equivalent	Imex Medical Systems, Inc.
K875179	MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A	Sep 19, 1988	Substantially Equivalent	Tsi, Inc.
K882593	MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM	Aug 29, 1988	Substantially Equivalent	Cardio Metrics, Inc.
K872048	TRANSONIC FLOWMETER	Jun 21, 1988	Substantially Equivalent	Transonic Systems, Inc.
K874885	LAWRENCE L3000 CARDIAC OUTPUT MONITOR	Feb 05, 1988	Substantially Equivalent	Lawrence Medical Systems, Inc.
K871490	COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION	Dec 07, 1987	Substantially Equivalent	Ge Medical Systems Information Technologies
K872068	HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD	Sep 30, 1987	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K864259	MODIFIED LASERFLO BLOOD PERFUSION MONITOR	Feb 20, 1987	Substantially Equivalent	Tsi, Inc.
K853952	METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME	Jan 05, 1987	Substantially Equivalent	Metriflow, Inc.
K863210	VELCOM-100	Nov 26, 1986	Substantially Equivalent	Waters Instruments, Inc.
K862720	VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES	Nov 17, 1986	Substantially Equivalent	Sonicaid, Inc.
K861023	DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER	Nov 17, 1986	Substantially Equivalent	Diagnostic Electronics Corp.
K862841	HIGH VELOCITY CW DOPPLER SYSTEM	Nov 10, 1986	Substantially Equivalent	Biosound, Inc.
K860766	MILLAR PULSED DOPPLER VELOCIMETER	Jul 29, 1986	Substantially Equivalent	Millar Instruments, Inc.
K860651	MICRON, MICROVASCULAR DOPPLER	Jul 18, 1986	Substantially Equivalent	Diagnostic Electronics Corp.
K854500	HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER -	Feb 26, 1986	Substantially Equivalent	Medpacific Corp.
K850137	TECA TC2-64 TRANSCRANIAL DOPPLER	Aug 14, 1985	Substantially Equivalent	Teca, Inc.
K851057	LASERFLO BLOOD PERFUSION MONITOR 403	Jun 24, 1985	Substantially Equivalent	Tsi, Inc.
K840522	RECOMED BLOOD-FLOW METER H236-052-02	May 16, 1985	Substantially Equivalent	Litton Medical Electronics
K840169	PHONOANGIOGRAPHIC SPECTRAL ANALYZER	Mar 01, 1985	Substantially Equivalent	Biotronics Instruments
K844631	PERIFLUX PF-2	Feb 20, 1985	Substantially Equivalent	Medex, Inc.
K821373	XOMED PATENCY MONITOR	Jul 08, 1982	Substantially Equivalent	Xomed, Inc.
K820742	NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100	Apr 15, 1982	Substantially Equivalent	Nihon Kohden America, Inc.
K820272	CLINIFLOW II, #701, ELECTROMAGN. BLD. SY	Mar 12, 1982	Substantially Equivalent	Carolina Medical Electronics
K812005	CAPILLARY PERFUSION MONITOR #LD5000	Feb 04, 1982	Substantially Equivalent	Nuclear Pacific, Inc.
K811616	BACH-SIMPSON MODEL TS266	Aug 13, 1981	Substantially Equivalent	Bach-Simpson , Ltd.
K811615	BACH-SIMPSON MODEL BVM30	Aug 13, 1981	Substantially Equivalent	Bach-Simpson , Ltd.
K811376	ULTRASONIC QFM SYSTEM 1000	Aug 13, 1981	Substantially Equivalent	Narco Bio-Systems
K811246	DOPPLER ULTRASOUND BLOOD FLOWMETER	Aug 12, 1981	Substantially Equivalent	Irex Corp.
K810561	DOPSCAN MODEL 1050	Apr 10, 1981	Substantially Equivalent	Carolina Medical Electronics
K801802	ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE	Jan 02, 1981	Substantially Equivalent	Medical Testing System, Inc.
K800151	EMIT TOBRAMYCIN CONTROL	Feb 05, 1980	Substantially Equivalent	Syva Co.
K791418	VASCULIZER	Oct 04, 1979	Substantially Equivalent	Diagnostics Intl.
K780302	BLOOD FLOWMETER SYSTEM	Apr 21, 1978	Substantially Equivalent	Medtronic Vascular
K770115	ARTERIAL DIAGNOSTIC UNIT (ADU)	Feb 01, 1977	Substantially Equivalent	Medical Electronic Devices, Inc.
K761288	P-1 ULTRASONIC ARTERIOGRAPH	Dec 28, 1976	Substantially Equivalent	D. Eugene Hokanson
K760751	CONTINUOUS WAVE DOPPLER	Oct 13, 1976	Substantially Equivalent	Medsonics