Panels › Cardiovascular › Product code DPW · Class 2
Flowmeter, Blood, Cardiovascular
Regulation 870.2100
3510(k)s in 12 months (138 all time)
1recalls in 12 months (35 all time)
31recalls that name a 510(k)
Top companies in DPW
| Company | 510(k)s | Recalls |
|---|---|---|
| Transonic Systems, Inc. | 5 | 10 |
| Koven Technology, Inc. | 7 | 1 |
| Baxter Healthcare Corp. | 0 | 7 |
| Vascular Technology Incorporated | 2 | 5 |
| Deltex Medical | 6 | 0 |
| Perimed AB | 6 | 0 |
| Koven and Assoc., Inc. | 5 | 0 |
| Parks Medical Electronics Inc | 0 | 5 |
| Cardio Metrics, Inc. | 4 | 0 |
| Flosonics Medical | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 2026 | K260700 | BlueDop Vascular Expert BlueDop Medical, Ltd., GB | DPW |
| Apr 24, 2026 | K252810 | FloPatch FP120 Flosonics Medical, CA | DPW |
| Nov 20, 2025 | K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, Remington Medical, Inc. | DPW |
| Jun 20, 2025 | K251114 | FloPatch FP120 Flosonics Medical, CA | DPW |
| Apr 14, 2025 | K243852 | Elfor-L Elfi-Tech , Ltd., IL | DPW |
| Aug 30, 2024 | K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH Remington Medical, Inc. | DPW |
| May 3, 2023 | K223843 | FloPatch FP120 Flosonics Medical, CA | DPW |
| Dec 9, 2022 | K222242 | FloPatch FP120 Flosonics Medical, CA | DPW |
| Apr 20, 2022 | K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) Synovis Micro Companies Alliance, Inc. | DPW |
| Jan 27, 2022 | K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger Remington Medical, Inc. | DPW |
| Oct 7, 2021 | K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger Remington Medical, Inc. | DPW |
| Jan 5, 2021 | K201114 | Bidop 7 Koven Technology, Inc. | DPW |
| Mar 24, 2020 | K200337 | FloPatch (FP120) Flosonics Medical (R/A 1929803 Ontario Corp.), CA | DPW |
| Jan 10, 2020 | K192966 | FlowMet Laser Associated Sciences, Inc. | DPW |
| Sep 6, 2019 | K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes Huntleigh Healthcare , Ltd., GB | DPW |
| Jun 21, 2019 | K191388 | FloPatch (FP110) Flosonics Medical (R/A 1929803 Ontario Corp.), CA | DPW |
| Feb 27, 2019 | K182494 | FlowMet-R Laser Associated Sciences, Inc. | DPW |
| Dec 14, 2018 | K181269 | iCertainty Rfpi | DPW |
| Jun 28, 2018 | K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM Deltex Medical Limited, GB | DPW |
| May 5, 2016 | K152930 | PeriFlux6000 Perimed AB, SE | DPW |
| Nov 6, 2015 | K150268 | CerOX Or-Nim Medical , Ltd., IL | DPW |
| Jul 24, 2015 | K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ Deltex Medical Limited, GB | DPW |
| Jul 23, 2015 | K140740 | TRANSONIC TISSUE PERFUSION MONITOR Transonic Systems, Inc. | DPW |
| Oct 10, 2013 | K132139 | DELTEX MEDICAL CARDIOQ-EDM+ Deltex Medical Limited | DPW |
| Sep 13, 2013 | K131854 | CEROX Or-Nim Medical , Ltd., IL | DPW |
| Jan 6, 2012 | K111730 | SONOTT FLOWLAB(R) Em-Tec GmbH, DE | DPW |
| Dec 21, 2011 | K112657 | AUREFLO MONITORING SYSTEM Transonic Systems, Inc. | DPW |
| Oct 20, 2011 | K111542 | DELTEX MEDICAL CARDIOQ EDM Deltex Medical Limited, GB | DPW |
| May 4, 2011 | K110438 | SENSILASE PAD-IQ Vasamed, Inc. | DPW |
| Mar 16, 2011 | K110347 | DOPPLER MONITOR Cook Vascular, Inc. | DPW |
| Dec 27, 2010 | K102595 | MEDISTIM VERIQC SYSTEM Medi-Stim Asa | DPW |
| Nov 18, 2010 | K102433 | MOORVMS-PRES PRESSURE CUFF CONTROLLER Moor Instruments, Ltd., GB | DPW |
| Oct 28, 2008 | K082870 | VTI INTRAOPERATIVE DOPPLER SYSTEMS Vascular Technology Incorporated | DPW |
| Feb 28, 2007 | K062977 | CRITIVIEW, MODEL CRV3 Critisense , Ltd. | DPW |
| Jan 18, 2006 | K051145 | CRITIVIEW Critisense , Ltd. | DPW |
| Sep 6, 2005 | K052209 | VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 Vascular Control Systems, Inc. | DPW |
| Apr 15, 2005 | K050601 | SMARTDOP 45 VASCULAR DOPPLER Koven Technology, Inc. | DPW |
| Feb 8, 2005 | K050088 | QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER Neoprobe Corp. | DPW |
| Jun 7, 2004 | K041180 | QUANTIX OR VESSEL STABILIZER DEVICE Cardiosonix, Ltd., IL | DPW |
| Jun 4, 2004 | K040654 | SENSILASE PAD 3000 Optical Sensors, Inc. | DPW |
| Apr 29, 2004 | K040228 | MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 Medi-Stim A/S | DPW |
| Apr 20, 2004 | K040909 | SONO TT ULTRASONIC FLOWCOMPUTER Em-Tec GmbH, DE | DPW |
| Feb 13, 2004 | K031931 | ECHO SOUNDER EX-101EX 8 MHZ Koven Technology, Inc. | DPW |
| Dec 11, 2003 | K033424 | ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 Transonic Systems, Inc. | DPW |
| Nov 25, 2003 | K031153 | MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 Arrow Intl., Inc. | DPW |
| Aug 20, 2003 | K030357 | QUANTIX/OR DEVICE Cardiosonix, Ltd., IL | DPW |
| Aug 6, 2003 | K031706 | CARDIOQ, MODEL 9051-7005 Deltex Medical, GB | DPW |
| May 14, 2003 | K030505 | CAPIOX CARDIOTOMY RESERVOIR Terumo Cardiovascular Systems Corp. | DPW |
| Apr 23, 2003 | K031091 | VTI 20 MHZ GATED DOPPLER Vascular Technology Incorporated | DPW |
| Nov 13, 2002 | K023431 | QUANTIX/ND DEVICE Cardiosonix, Ltd., IL | DPW |
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