FDA Product Code
FDA Product Code DPW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2100
510(k) Clearances — 138 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260700 | BlueDop Vascular Expert | BlueDop Medical, Ltd. | 2026-07-08 | Traditional | PDF ↗ |
| K252810 | FloPatch FP120 | Flosonics Medical | 2026-04-24 | Special | PDF ↗ |
| 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) | Remington Medical, Inc. | 2025-11-20 | Traditional | PDF ↗ |
| K251114 | FloPatch FP120 | Flosonics Medical | 2025-06-20 | Traditional | PDF ↗ |
| K243852 | Elfor-L | Elfi-Tech , Ltd. | 2025-04-14 | Traditional | PDF ↗ |
| 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) | Remington Medical, Inc. | 2024-08-30 | Special | PDF ↗ |
| K223843 | FloPatch FP120 | Flosonics Medical | 2023-05-03 | Traditional | PDF ↗ |
| K222242 | FloPatch FP120 | Flosonics Medical | 2022-12-09 | Traditional | PDF ↗ |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | Synovis Micro Companies Alliance, Inc. | 2022-04-20 | Special | PDF ↗ |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | Remington Medical, Inc. | 2022-01-27 | Traditional | PDF ↗ |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | Remington Medical, Inc. | 2021-10-07 | Traditional | PDF ↗ |
| K201114 | Bidop 7 | Koven Technology, Inc. | 2021-01-05 | Traditional | PDF ↗ |
| K200337 | FloPatch (FP120) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2020-03-24 | Traditional | PDF ↗ |
| K192966 | FlowMet | Laser Associated Sciences, Inc. | 2020-01-10 | Special | PDF ↗ |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Huntleigh Healthcare , Ltd. | 2019-09-06 | Abbreviated | PDF ↗ |
| K191388 | FloPatch (FP110) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2019-06-21 | Traditional | PDF ↗ |
| K182494 | FlowMet-R | Laser Associated Sciences, Inc. | 2019-02-27 | Traditional | PDF ↗ |
| K181269 | iCertainty | Rfpi | 2018-12-14 | Traditional | PDF ↗ |
| K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited | 2018-06-28 | Traditional | PDF ↗ |
| K152930 | PeriFlux6000 | Perimed AB | 2016-05-05 | Traditional | PDF ↗ |
| K150268 | CerOX | Or-Nim Medical , Ltd. | 2015-11-06 | Traditional | PDF ↗ |
| K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ | Deltex Medical Limited | 2015-07-24 | Traditional | PDF ↗ |
| K140740 | TRANSONIC TISSUE PERFUSION MONITOR | Transonic Systems, Inc. | 2015-07-23 | Traditional | PDF ↗ |
| K132139 | DELTEX MEDICAL CARDIOQ-EDM+ | Deltex Medical Limited | 2013-10-10 | Traditional | PDF ↗ |
| K131854 | CEROX | Or-Nim Medical , Ltd. | 2013-09-13 | Special | PDF ↗ |
| K111730 | SONOTT FLOWLAB(R) | Em-Tec GmbH | 2012-01-06 | Abbreviated | PDF ↗ |
| K112657 | AUREFLO MONITORING SYSTEM | Transonic Systems, Inc. | 2011-12-21 | Traditional | PDF ↗ |
| K111542 | DELTEX MEDICAL CARDIOQ EDM | Deltex Medical Limited | 2011-10-20 | Traditional | PDF ↗ |
| K110438 | SENSILASE PAD-IQ | Vasamed, Inc. | 2011-05-04 | Abbreviated | PDF ↗ |
| K110347 | DOPPLER MONITOR | Cook Vascular, Inc. | 2011-03-16 | Special | PDF ↗ |
| K102595 | MEDISTIM VERIQC SYSTEM | Medi-Stim Asa | 2010-12-27 | Traditional | PDF ↗ |
| K102433 | MOORVMS-PRES PRESSURE CUFF CONTROLLER | Moor Instruments, Ltd. | 2010-11-18 | Traditional | PDF ↗ |
| K082870 | VTI INTRAOPERATIVE DOPPLER SYSTEMS | Vascular Technology Incorporated | 2008-10-28 | Special | PDF ↗ |
| K062977 | CRITIVIEW, MODEL CRV3 | Critisense , Ltd. | 2007-02-28 | Traditional | PDF ↗ |
| K051145 | CRITIVIEW | Critisense , Ltd. | 2006-01-18 | Traditional | PDF ↗ |
| K052209 | VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 | Vascular Control Systems, Inc. | 2005-09-06 | Traditional | PDF ↗ |
| K050601 | SMARTDOP 45 VASCULAR DOPPLER | Koven Technology, Inc. | 2005-04-15 | Traditional | PDF ↗ |
| K050088 | QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER | Neoprobe Corp. | 2005-02-08 | Special | PDF ↗ |
| K041180 | QUANTIX OR VESSEL STABILIZER DEVICE | Cardiosonix, Ltd. | 2004-06-07 | Special | PDF ↗ |
| K040654 | SENSILASE PAD 3000 | Optical Sensors, Inc. | 2004-06-04 | Abbreviated | PDF ↗ |
| K040228 | MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 | Medi-Stim A/S | 2004-04-29 | Traditional | PDF ↗ |
| K040909 | SONO TT ULTRASONIC FLOWCOMPUTER | Em-Tec GmbH | 2004-04-20 | Traditional | PDF ↗ |
| K031931 | ECHO SOUNDER EX-101EX 8 MHZ | Koven Technology, Inc. | 2004-02-13 | Traditional | PDF ↗ |
| K033424 | ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 | Transonic Systems, Inc. | 2003-12-11 | Special | PDF ↗ |
| K031153 | MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 | Arrow Intl., Inc. | 2003-11-25 | Traditional | PDF ↗ |
| K030357 | QUANTIX/OR DEVICE | Cardiosonix, Ltd. | 2003-08-20 | Traditional | PDF ↗ |
| K031706 | CARDIOQ, MODEL 9051-7005 | Deltex Medical | 2003-08-06 | Traditional | PDF ↗ |
| K030505 | CAPIOX CARDIOTOMY RESERVOIR | Terumo Cardiovascular Systems Corp. | 2003-05-14 | Traditional | PDF ↗ |
| K031091 | VTI 20 MHZ GATED DOPPLER | Vascular Technology Incorporated | 2003-04-23 | Traditional | PDF ↗ |
| K023431 | QUANTIX/ND DEVICE | Cardiosonix, Ltd. | 2002-11-13 | Special | PDF ↗ |
| K013376 | QFLOW 500 PERFUSION MONITORING SYSTEM | Hemedex Incorporated | 2002-05-08 | Traditional | PDF ↗ |
| K013803 | FLOWGUARD DEVICE | Biosonix , Ltd. | 2002-02-13 | Traditional | PDF ↗ |
| K010452 | BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T | Koven Technology, Inc. | 2002-02-12 | Traditional | PDF ↗ |
| K011899 | PF 5050 PRESSURE UNIT, MODEL PF 5050 | Perimed AB | 2001-11-06 | Traditional | PDF ↗ |
| K002186 | VASCULAR ASSIST | Huntleigh Healthcare, Inc. | 2001-05-02 | Traditional | PDF ↗ |
| K992529 | TISSUE SPECTROSCOPE | Vital Medical , Ltd. | 2000-11-17 | Traditional | PDF ↗ |
| K984338 | JOSTRA HL-20 TWIN PUMP | Jostra Bentley | 1999-08-19 | Traditional | PDF ↗ |
| K992387 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100 | Rossmax International , Ltd. | 1999-08-03 | Special | PDF ↗ |
| K992388 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200 | Rossmax International , Ltd. | 1999-08-03 | Special | PDF ↗ |
| K973078 | WRIST BLOOD PRESSURE METER MODEL SE-330 | Sein Electronics Co., Ltd. | 1999-05-20 | Traditional | PDF ↗ |
| K982986 | TUBING BLOOD FLOW METER MODEL NUMBER HD-800 | Koven Technology, Inc. | 1998-11-24 | Traditional | PDF ↗ |
| K973198 | VGF-7 VASCULAR GRAFT FLOWMETER | Medicard , Ltd. | 1998-10-14 | Traditional | PDF ↗ |
| K974285 | PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT | Perimed, Inc. | 1998-05-28 | Traditional | PDF ↗ |
| K970211 | MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR | Micro Weiss Electronics | 1998-04-30 | Traditional | PDF ↗ |
| K970139 | MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO | Micro Weiss Electronics | 1998-04-30 | Traditional | PDF ↗ |
| K972213 | MS-700 | Alan S. Lee | 1998-03-13 | Traditional | PDF ↗ |
| K972798 | DYNEMO 3000 | Sometec, Inc. | 1998-02-24 | Traditional | PDF ↗ |
| K954397 | BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY | Koven Technology, Inc. | 1996-03-29 | Traditional | PDF ↗ |
| K951369 | EDM | Deltex Medical | 1995-11-07 | Traditional | PDF ↗ |
| K951486 | MODEL PV2000 VASCULAR MICROLABORATORY | Vasamedics, LLC | 1995-06-29 | Traditional | PDF ↗ |
| K942613 | SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR | Koven Technology, Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K932068 | PERITEMP PF 4005 HEATER | Perimed, Inc. | 1993-12-07 | Traditional | PDF ↗ |
| K921377 | P/METER | Zertl Medical, Inc. | 1993-10-12 | Traditional | PDF ↗ |
| K930227 | MS DISPOSABLE RIGID DOPPLER PROBE | Meadox Medicals, Div. Boston Scientific Corp. | 1993-09-16 | Traditional | PDF ↗ |
| K925524 | CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) | Cardio Metrics, Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K922034 | LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER | Titronics Medical Instruments, Inc. | 1993-05-18 | Traditional | PDF ↗ |
| K922368 | PERIFLUX PF4001 LASER DOPPLER FLOWMETER | Perimed, Inc. | 1993-02-03 | Traditional | PDF ↗ |
| K922669 | MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW | Koven and Assoc., Inc. | 1993-01-29 | Traditional | PDF ↗ |
| K920333 | SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR | Koven and Assoc., Inc. | 1993-01-22 | Traditional | PDF ↗ |
| K915550 | MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR | Koven and Assoc., Inc. | 1992-12-10 | Traditional | PDF ↗ |
| K920844 | PIM 1.0 LASER DOPPLER PERFUSION IMAGER | Lisca Development AB | 1992-07-21 | Traditional | PDF ↗ |
| K912562 | ABCOM 2000 | Applied Biometrics, Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K912446 | MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 | Vasamedics, LLC | 1991-12-12 | Traditional | PDF ↗ |
| K913827 | MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG | Hewlett-Packard Co. | 1991-11-19 | Traditional | PDF ↗ |
| K911763 | LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) | Vasamedics, LLC | 1991-08-13 | Traditional | PDF ↗ |
| K910049 | INTERSPEC APOGEE, MODIFICATION | Interspec, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K905411 | FLOWIRE AND FLOMAP | Cardio Metrics, Inc. | 1991-03-29 | Traditional | PDF ↗ |
| K903026 | ES-1000SP II SMART DOP | Koven and Assoc., Inc. | 1991-02-26 | Traditional | PDF ↗ |
| K904317 | AVALON GENERAL PURPOSE SCANNER, PREVIEW GP | Avalon Technology Corp. | 1991-02-13 | Traditional | PDF ↗ |
| K904792 | DIAGNOSTIC ULTRASOUND VERSADOPP 1000 | Diagnostic Ultrasound Corp. | 1991-01-28 | Traditional | PDF ↗ |
| K903625 | DOPPLER NEEDLE AND FLOW MONITOR | Peripheral Systems Group | 1990-11-07 | Traditional | PDF ↗ |
| K901015 | WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC | Wright Medical Corp. | 1990-11-05 | Traditional | PDF ↗ |
| K903633 | ADVANCE LASER FLOWMETER, ALF 21 | Transonic Systems, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K901335 | ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER | Ge Medical Systems Information Technologies | 1990-08-10 | Traditional | PDF ↗ |
| K902088 | MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND | Hewlett-Packard Co. | 1990-08-08 | Traditional | PDF ↗ |
| K901733 | MODIFIED FLOCATH PULMONARY ARTERY CATHETER | Cardio Metrics, Inc. | 1990-07-16 | Traditional | PDF ↗ |
| K896613 | FLAT VASCULAR PROBE | Imex Medical Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K896515 | LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2 | Tsi, Inc. | 1990-02-13 | Traditional | PDF ↗ |
| K894631 | NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW. | Nihon Kohden America, Inc. | 1990-01-19 | Traditional | PDF ↗ |
| K892707 | DVM-4200 BLOOD FLOWMETER | Koven and Assoc., Inc. | 1989-07-28 | Traditional | PDF ↗ |
Product code DPW · Class II · Cardiovascular. Data: openFDA.