Product Code: DPT FDA class 2 21 CFR 870.2120

Probe, Blood-Flow, Extravascular

Cardiovascular

The Probe, Blood-Flow, Extravascular is a clinical device used to measure blood flow in vessels from outside the vessel wall, typically using Doppler or electromagnetic techniques during surgical procedures or diagnostic evaluations of vascular function. It is a Class 2 device requiring a 510(k) premarket notification to demonstrate substantial equivalence before marketing. The product code is DPT, regulated under 21 CFR 870.2120, within the Cardiovascular medical specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DPT
Device Class: FDA class 2
Regulation Number: 870.2120
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 48 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233076	Laser Speckle Imaging System (RFLSI CZW)	May 28, 2024	Substantially Equivalent	Rwd Life Science Co., Ltd.
K163339	SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0	Aug 17, 2017	Substantially Equivalent	Spectralmd, Inc.
K152749	moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager	May 12, 2016	Substantially Equivalent	Moor Instruments, Ltd.
K142932	Deltex Medical KDP72 Doppler Probe	Jan 22, 2015	Substantially Equivalent	Deltex Medical Limited
K132730	BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE	May 30, 2014	Substantially Equivalent	Medtronic, Inc.
K133903	BIO-PROBE TRANSDUCER (ADULT)	Apr 10, 2014	Substantially Equivalent	Medtronic, Inc.
K132163	MOORLDLS-BI LASER DOPPLER BURNS IMAGER	Jan 29, 2014	Substantially Equivalent	Moor Instruments, Ltd.
K124049	DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM	Apr 18, 2013	Substantially Equivalent	Spectralmd, Inc.
K123216	AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN	Feb 07, 2013	Substantially Equivalent	Aimago SA
K122943	MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER	Jan 03, 2013	Substantially Equivalent	Moor Instruments, Ltd.
K121429	AIMAGO EASYLDI MICROCIRCULATION CAMERA	Aug 10, 2012	Substantially Equivalent	Aimago SA
K120884	PERICAM PSI	Jul 03, 2012	Substantially Equivalent	Perimed AB
K073593	I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016	Jan 29, 2009	Substantially Equivalent	Deltex Medical Limited
K060976	MOORLD12-B1 LASER DOPPLER BURNS IMAGER	Mar 27, 2007	Substantially Equivalent	Moor Instruments, Ltd.
K063586	MOORFLPI FULL-FIELD LASER PERFUSION IMAGER	Jan 25, 2007	Substantially Equivalent	Moor Instruments, Ltd.
K063561	MOORLDLS LASER DOPPLER LINE SCANNER	Jan 19, 2007	Substantially Equivalent	Moor Instruments, Ltd.
K052989	DP240 240 HOUR DOPPLER PROBE	Mar 08, 2006	Substantially Equivalent	Deltex Medical
K032841	MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR	Dec 10, 2003	Substantially Equivalent	Moor Instruments, Ltd.
K013939	JOSTRA FLOWPROBE FP-32E	Dec 14, 2001	Substantially Equivalent	Jostra AG
K012747	TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)	Sep 14, 2001	Substantially Equivalent	Medtronic Perfusion Systems
K980383	MOOORLDI LASER DOPPLER IMAGER	Apr 30, 1998	Substantially Equivalent	Moor Instruments, Ltd.
K963703	ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)	Apr 08, 1998	Substantially Equivalent	International Biophysics Corp.
K962700	VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT	Apr 09, 1997	Substantially Equivalent	Vasamedics, LLC
K961368	TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT	Oct 11, 1996	Unknown	Vasamedics, LLC
K951832	LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433	Mar 21, 1996	Substantially Equivalent	Vasamedics, LLC
K942377	TRANSTAR PRESSURE TRANSDUCER	Aug 16, 1994	Substantially Equivalent	Medex, Inc.
K924208	BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)	Jul 08, 1993	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K902977	K3 COMPUTER SYSTEMS	Apr 28, 1992	Substantially Equivalent	Donald L. King M.D.
K912404	TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY	Nov 07, 1991	Substantially Equivalent	Hewlett-Packard Co.
K910441	FLOSCOPE MICRODOP	Mar 21, 1991	Substantially Equivalent	Advance Medical Device, Inc.
K905728	SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM	Mar 15, 1991	Substantially Equivalent	Hewlett-Packard Co.
K896437	KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM	Dec 03, 1990	Substantially Equivalent	Kontron Instruments, Inc.
K896435	HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM	Feb 07, 1990	Substantially Equivalent	Hewlett-Packard Co.
K881303	TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER	Nov 29, 1988	Substantially Equivalent	Triton Technology, Inc.
K874138	ACCUCOM 2	Jun 01, 1988	Substantially Equivalent	Datascope Corp.
K873214	APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300	Jun 01, 1988	Substantially Equivalent	General Electric Co.
K874861	ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.	May 11, 1988	Substantially Equivalent	Acuson Computed Sonography
K875266	SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM	Apr 29, 1988	Substantially Equivalent	Toshiba Medical Systems
K873673	BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL	Feb 26, 1988	Substantially Equivalent	Sonicaid, Inc.
K872441	HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR	Feb 19, 1988	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K871912	PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM	Feb 18, 1988	Substantially Equivalent	Electro-Diagnostic Instruments
K873041	A-V RECORDER	Feb 04, 1988	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K863372	SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES	Nov 04, 1986	Substantially Equivalent	Interspec, Inc.
K860121	INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER	Jun 02, 1986	Substantially Equivalent	NuMED, Inc.
K860435	MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER	May 05, 1986	Substantially Equivalent	Multigon Industries, Inc.
K830858	BIO-PROBE SYSTEM-BLOOD FLOW PROBE	Jun 08, 1983	Substantially Equivalent	Bio Medicus, Inc.
K792015	P-2 ULTRASONIC ARTERIOGRAPH	Dec 04, 1979	Substantially Equivalent	D. E. Hokanson, Inc.
K781413	MASK, PXYGEN	Sep 07, 1978	Substantially Equivalent	Vitalab Products Corp.