Atlas FDA

DPT

48 FDA 510(k) clearances · Product code

140 daysmedian time to decision
351 days90th percentile
48clearances measured

FDA profile

Official device name
Probe, Blood-Flow, Extravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2120
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 13 · 2022: 46 · 2023: 21 · 2024: 169 · 2025: 53 · 2026: 43
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Laser Speckle Imaging System (RFLSI CZW) (K233076)Rwd Life Science Co., Ltd.2024-05-28
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 (K163339)Spectralmd, Inc.2017-08-17
moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager (K152749)Moor Instruments, Ltd.2016-05-12
Deltex Medical KDP72 Doppler Probe (K142932)Deltex Medical Limited2015-01-22
BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE (K132730)Medtronic, Inc.2014-05-30
BIO-PROBE TRANSDUCER (ADULT) (K133903)Medtronic, Inc.2014-04-10
MOORLDLS-BI LASER DOPPLER BURNS IMAGER (K132163)Moor Instruments, Ltd.2014-01-29
DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM (K124049)Spectralmd, Inc.2013-04-18
AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN (K123216)Aimago SA2013-02-07
MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER (K122943)Moor Instruments, Ltd.2013-01-03
AIMAGO EASYLDI MICROCIRCULATION CAMERA (K121429)Aimago SA2012-08-10
PERICAM PSI (K120884)Perimed AB2012-07-03
I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 (K073593)Deltex Medical Limited2009-01-29
MOORLD12-B1 LASER DOPPLER BURNS IMAGER (K060976)Moor Instruments, Ltd.2007-03-27
MOORFLPI FULL-FIELD LASER PERFUSION IMAGER (K063586)Moor Instruments, Ltd.2007-01-25
MOORLDLS LASER DOPPLER LINE SCANNER (K063561)Moor Instruments, Ltd.2007-01-19
DP240 240 HOUR DOPPLER PROBE (K052989)Deltex Medical2006-03-08
MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR (K032841)Moor Instruments, Ltd.2003-12-10
JOSTRA FLOWPROBE FP-32E (K013939)Jostra AG2001-12-14
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) (K012747)Medtronic Perfusion Systems2001-09-14
MOOORLDI LASER DOPPLER IMAGER (K980383)Moor Instruments, Ltd.1998-04-30
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) (K963703)International Biophysics Corp.1998-04-08
VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT (K962700)Vasamedics, LLC1997-04-09
TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT (K961368)Vasamedics, LLC1996-10-11
LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433 (K951832)Vasamedics, LLC1996-03-21
TRANSTAR PRESSURE TRANSDUCER (K942377)Medex, Inc.1994-08-16
BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) (K924208)Medtronic Bio-Medicus, Inc.1993-07-08
K3 COMPUTER SYSTEMS (K902977)Donald L. King M.D.1992-04-28
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY (K912404)Hewlett-Packard Co.1991-11-07
FLOSCOPE MICRODOP (K910441)Advance Medical Device, Inc.1991-03-21
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM (K905728)Hewlett-Packard Co.1991-03-15
KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM (K896437)Kontron Instruments, Inc.1990-12-03
HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM (K896435)Hewlett-Packard Co.1990-02-07
TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER (K881303)Triton Technology, Inc.1988-11-29
ACCUCOM 2 (K874138)Datascope Corp.1988-06-01
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300 (K873214)General Electric Co.1988-06-01
ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. (K874861)Acuson Computed Sonography1988-05-11
SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM (K875266)Toshiba Medical Systems1988-04-29
BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL (K873673)Sonicaid, Inc.1988-02-26
HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR (K872441)Advanced Technology Laboratories, Inc.1988-02-19
PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM (K871912)Electro-Diagnostic Instruments1988-02-18
A-V RECORDER (K873041)Life Sciences Manufacturing, Inc.1988-02-04
SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES (K863372)Interspec, Inc.1986-11-04
INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER (K860121)NuMED, Inc.1986-06-02
MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER (K860435)Multigon Industries, Inc.1986-05-05
BIO-PROBE SYSTEM-BLOOD FLOW PROBE (K830858)Bio Medicus, Inc.1983-06-08
P-2 ULTRASONIC ARTERIOGRAPH (K792015)D. E. Hokanson, Inc.1979-12-04
MASK, PXYGEN (K781413)Vitalab Products Corp.1978-09-07

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Every clearance here is in the API, with alerts when new ones post.