Atlas FDA

DPW

138 FDA 510(k) clearances · Product code

124 daysmedian time to decision
362 days90th percentile
138clearances measured

FDA profile

Official device name
Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2001: 1 · 2003: 1 · 2004: 1 · 2005: 9 · 2014: 8 · 2015: 12
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
BlueDop Vascular Expert (K260700)BlueDop Medical, Ltd.2026-07-08
FloPatch FP120 (K252810)Flosonics Medical2026-04-24
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) (K251904)Remington Medical, Inc.2025-11-20
FloPatch FP120 (K251114)Flosonics Medical2025-06-20
Elfor-L (K243852)Elfi-Tech , Ltd.2025-04-14
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) (K241583)Remington Medical, Inc.2024-08-30
FloPatch FP120 (K223843)Flosonics Medical2023-05-03
FloPatch FP120 (K222242)Flosonics Medical2022-12-09
GEM FLOW COUPLER Monitor (GEM1020M-2) (K213974)Synovis Micro Companies Alliance, Inc.2022-04-20
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (K211589)Remington Medical, Inc.2022-01-27
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (K212065)Remington Medical, Inc.2021-10-07
Bidop 7 (K201114)Koven Technology, Inc.2021-01-05
FloPatch (FP120) (K200337)Flosonics Medical (R/A 1929803 Ontario Corp.)2020-03-24
FlowMet (K192966)Laser Associated Sciences, Inc.2020-01-10
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes (K183574)Huntleigh Healthcare , Ltd.2019-09-06
FloPatch (FP110) (K191388)Flosonics Medical (R/A 1929803 Ontario Corp.)2019-06-21
FlowMet-R (K182494)Laser Associated Sciences, Inc.2019-02-27
iCertainty (K181269)Rfpi2018-12-14
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM (K172457)Deltex Medical Limited2018-06-28
PeriFlux6000 (K152930)Perimed AB2016-05-05
CerOX (K150268)Or-Nim Medical , Ltd.2015-11-06
Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ (K150347)Deltex Medical Limited2015-07-24
TRANSONIC TISSUE PERFUSION MONITOR (K140740)Transonic Systems, Inc.2015-07-23
DELTEX MEDICAL CARDIOQ-EDM+ (K132139)Deltex Medical Limited2013-10-10
CEROX (K131854)Or-Nim Medical , Ltd.2013-09-13
SONOTT FLOWLAB(R) (K111730)Em-Tec GmbH2012-01-06
AUREFLO MONITORING SYSTEM (K112657)Transonic Systems, Inc.2011-12-21
DELTEX MEDICAL CARDIOQ EDM (K111542)Deltex Medical Limited2011-10-20
SENSILASE PAD-IQ (K110438)Vasamed, Inc.2011-05-04
DOPPLER MONITOR (K110347)Cook Vascular, Inc.2011-03-16
MEDISTIM VERIQC SYSTEM (K102595)Medi-Stim Asa2010-12-27
MOORVMS-PRES PRESSURE CUFF CONTROLLER (K102433)Moor Instruments, Ltd.2010-11-18
VTI INTRAOPERATIVE DOPPLER SYSTEMS (K082870)Vascular Technology Incorporated2008-10-28
CRITIVIEW, MODEL CRV3 (K062977)Critisense , Ltd.2007-02-28
CRITIVIEW (K051145)Critisense , Ltd.2006-01-18
VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 (K052209)Vascular Control Systems, Inc.2005-09-06
SMARTDOP 45 VASCULAR DOPPLER (K050601)Koven Technology, Inc.2005-04-15
QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER (K050088)Neoprobe Corp.2005-02-08
QUANTIX OR VESSEL STABILIZER DEVICE (K041180)Cardiosonix, Ltd.2004-06-07
SENSILASE PAD 3000 (K040654)Optical Sensors, Inc.2004-06-04
MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 (K040228)Medi-Stim A/S2004-04-29
SONO TT ULTRASONIC FLOWCOMPUTER (K040909)Em-Tec GmbH2004-04-20
ECHO SOUNDER EX-101EX 8 MHZ (K031931)Koven Technology, Inc.2004-02-13
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 (K033424)Transonic Systems, Inc.2003-12-11
MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 (K031153)Arrow Intl., Inc.2003-11-25
QUANTIX/OR DEVICE (K030357)Cardiosonix, Ltd.2003-08-20
CARDIOQ, MODEL 9051-7005 (K031706)Deltex Medical2003-08-06
CAPIOX CARDIOTOMY RESERVOIR (K030505)Terumo Cardiovascular Systems Corp.2003-05-14
VTI 20 MHZ GATED DOPPLER (K031091)Vascular Technology Incorporated2003-04-23
QUANTIX/ND DEVICE (K023431)Cardiosonix, Ltd.2002-11-13
QFLOW 500 PERFUSION MONITORING SYSTEM (K013376)Hemedex Incorporated2002-05-08
FLOWGUARD DEVICE (K013803)Biosonix , Ltd.2002-02-13
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T (K010452)Koven Technology, Inc.2002-02-12
PF 5050 PRESSURE UNIT, MODEL PF 5050 (K011899)Perimed AB2001-11-06
VASCULAR ASSIST (K002186)Huntleigh Healthcare, Inc.2001-05-02
TISSUE SPECTROSCOPE (K992529)Vital Medical , Ltd.2000-11-17
JOSTRA HL-20 TWIN PUMP (K984338)Jostra Bentley1999-08-19
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100 (K992387)Rossmax International , Ltd.1999-08-03
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200 (K992388)Rossmax International , Ltd.1999-08-03
WRIST BLOOD PRESSURE METER MODEL SE-330 (K973078)Sein Electronics Co., Ltd.1999-05-20
TUBING BLOOD FLOW METER MODEL NUMBER HD-800 (K982986)Koven Technology, Inc.1998-11-24
VGF-7 VASCULAR GRAFT FLOWMETER (K973198)Medicard , Ltd.1998-10-14
PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT (K974285)Perimed, Inc.1998-05-28
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR (K970211)Micro Weiss Electronics1998-04-30
MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO (K970139)Micro Weiss Electronics1998-04-30
MS-700 (K972213)Alan S. Lee1998-03-13
DYNEMO 3000 (K972798)Sometec, Inc.1998-02-24
BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY (K954397)Koven Technology, Inc.1996-03-29
EDM (K951369)Deltex Medical1995-11-07
MODEL PV2000 VASCULAR MICROLABORATORY (K951486)Vasamedics, LLC1995-06-29
SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR (K942613)Koven Technology, Inc.1994-12-23
PERITEMP PF 4005 HEATER (K932068)Perimed, Inc.1993-12-07
P/METER (K921377)Zertl Medical, Inc.1993-10-12
MS DISPOSABLE RIGID DOPPLER PROBE (K930227)Meadox Medicals, Div. Boston Scientific Corp.1993-09-16
CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) (K925524)Cardio Metrics, Inc.1993-08-23
LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER (K922034)Titronics Medical Instruments, Inc.1993-05-18
PERIFLUX PF4001 LASER DOPPLER FLOWMETER (K922368)Perimed, Inc.1993-02-03
MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW (K922669)Koven and Assoc., Inc.1993-01-29
SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR (K920333)Koven and Assoc., Inc.1993-01-22
MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR (K915550)Koven and Assoc., Inc.1992-12-10
PIM 1.0 LASER DOPPLER PERFUSION IMAGER (K920844)Lisca Development AB1992-07-21
ABCOM 2000 (K912562)Applied Biometrics, Inc.1992-01-09
MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 (K912446)Vasamedics, LLC1991-12-12
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG (K913827)Hewlett-Packard Co.1991-11-19
LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) (K911763)Vasamedics, LLC1991-08-13
INTERSPEC APOGEE, MODIFICATION (K910049)Interspec, Inc.1991-04-29
FLOWIRE AND FLOMAP (K905411)Cardio Metrics, Inc.1991-03-29
ES-1000SP II SMART DOP (K903026)Koven and Assoc., Inc.1991-02-26
AVALON GENERAL PURPOSE SCANNER, PREVIEW GP (K904317)Avalon Technology Corp.1991-02-13
DIAGNOSTIC ULTRASOUND VERSADOPP 1000 (K904792)Diagnostic Ultrasound Corp.1991-01-28
DOPPLER NEEDLE AND FLOW MONITOR (K903625)Peripheral Systems Group1990-11-07
WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC (K901015)Wright Medical Corp.1990-11-05
ADVANCE LASER FLOWMETER, ALF 21 (K903633)Transonic Systems, Inc.1990-10-09
ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER (K901335)Ge Medical Systems Information Technologies1990-08-10
MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND (K902088)Hewlett-Packard Co.1990-08-08
MODIFIED FLOCATH PULMONARY ARTERY CATHETER (K901733)Cardio Metrics, Inc.1990-07-16
FLAT VASCULAR PROBE (K896613)Imex Medical Systems, Inc.1990-02-16
LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2 (K896515)Tsi, Inc.1990-02-13
NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW. (K894631)Nihon Kohden America, Inc.1990-01-19
DVM-4200 BLOOD FLOWMETER (K892707)Koven and Assoc., Inc.1989-07-28
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