Product code DPW
- Device name
- Flowmeter, Blood, Cardiovascular
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2100
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252810 | FloPatch FP120 | Flosonics Medical | 2026-04-24 |
| 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-... | Remington Medical, Inc. | 2025-11-20 |
| K251114 | FloPatch FP120 | Flosonics Medical | 2025-06-20 |
| K243852 | Elfor-L | Elfi-Tech , Ltd. | 2025-04-14 |
| 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-... | Remington Medical, Inc. | 2024-08-30 |
| K223843 | FloPatch FP120 | Flosonics Medical | 2023-05-03 |
| K222242 | FloPatch FP120 | Flosonics Medical | 2022-12-09 |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | Synovis Micro Companies Alliance, Inc. | 2022-04-20 |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | Remington Medical, Inc. | 2022-01-27 |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | Remington Medical, Inc. | 2021-10-07 |
| K201114 | Bidop 7 | Koven Technology, Inc. | 2021-01-05 |
| K200337 | FloPatch (FP120) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2020-03-24 |
| K192966 | FlowMet | Laser Associated Sciences, Inc. | 2020-01-10 |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Huntleigh Healthcare , Ltd. | 2019-09-06 |
| K191388 | FloPatch (FP110) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2019-06-21 |
| K182494 | FlowMet-R | Laser Associated Sciences, Inc. | 2019-02-27 |
| K181269 | iCertainty | Rfpi | 2018-12-14 |
| K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited | 2018-06-28 |
| K152930 | PeriFlux6000 | Perimed AB | 2016-05-05 |
| K150268 | CerOX | Or-Nim Medical , Ltd. | 2015-11-06 |
| K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ | Deltex Medical Limited | 2015-07-24 |
| K140740 | TRANSONIC TISSUE PERFUSION MONITOR | Transonic Systems, Inc. | 2015-07-23 |
| K132139 | DELTEX MEDICAL CARDIOQ-EDM+ | Deltex Medical Limited | 2013-10-10 |
| K131854 | CEROX | Or-Nim Medical , Ltd. | 2013-09-13 |
| K111730 | SONOTT FLOWLAB(R) | Em-Tec GmbH | 2012-01-06 |
| K112657 | AUREFLO MONITORING SYSTEM | Transonic Systems, Inc. | 2011-12-21 |
| K111542 | DELTEX MEDICAL CARDIOQ EDM | Deltex Medical Limited | 2011-10-20 |
| K110438 | SENSILASE PAD-IQ | Vasamed, Inc. | 2011-05-04 |
| K110347 | DOPPLER MONITOR | Cook Vascular, Inc. | 2011-03-16 |
| K102595 | MEDISTIM VERIQC SYSTEM | Medi-Stim Asa | 2010-12-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00888937029536 | CooperSurgical® | Coopersurgical, Inc. | 2026-04-10 |
| 00888937027839 | CooperSurgical® | Coopersurgical, Inc. | 2026-04-01 |
| 00888937027815 | CooperSurgical® | Coopersurgical, Inc. | 2026-04-01 |
| 00627987360158 | Dual Adhesive Strap | 1929803 Ontario Corp | 2025-06-23 |
| 00813079022619 | VascuChek Surgical Probe | REMINGTON MEDICAL, INC. | 2024-08-23 |
| 00813079022657 | VascuChek Clinical Probe | REMINGTON MEDICAL, INC. | 2024-08-23 |
| 00627987360134 | Reprocess FloPatch | 1929803 Ontario Corp | 2023-05-08 |
| 00627987360141 | Dual Adhesive Strap | 1929803 Ontario Corp | 2023-03-03 |
| 00627987360110 | Hydrogel Adhesive Strap | 1929803 Ontario Corp | 2022-06-17 |
| 00860001276114 | FlowMet™ | MEDTRONIC, INC. | 2021-07-16 |
| 17332834000605 | PH 07-5 Small Tape-Fixated Probe Holder | Perimed AB | 2021-05-25 |
| 07070554101471 | Medistim MiraQ Ultimate System | Medistim ASA | 2017-07-03 |
| 07070554101396 | Medistim MiraQ Vascular System | Medistim ASA | 2017-07-03 |
| 15060484490096 | moorVMS-PC Software | MOOR INSTRUMENTS LIMITED | 2016-11-24 |
| 00844735005189 | GEM FLOW COUPLER External Lead | SYNOVIS MICRO COMPANIES ALLIANCE, INC | 2016-09-24 |
| 00634782053383 | Advantage™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 07070554101525 | Medistim MiraQ Vascular System | Medistim ASA | 2016-09-15 |
| 07070554101372 | Medistim MiraQ Vascular System | Medistim ASA | 2016-09-15 |
| 07070554101266 | Medistim VeriQCSystem | Medistim ASA | 2016-09-15 |
| 07070554101198 | Medistim VeriQ System | Medistim ASA | 2016-09-15 |
| 06944413801790 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 06944413801806 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 06944413801813 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 06944413802032 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 06944413801783 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 00894912002135 | Smartdop 45 | KOVEN TECHNOLOGY, INC. | 2016-02-24 |
| 00894912002098 | Smartdop 30EX | KOVEN TECHNOLOGY, INC. | 2016-02-24 |
| 00894912002050 | ES100VX | KOVEN TECHNOLOGY, INC. | 2016-02-24 |
| 00844735006018 | GEM FLOW COUPLER | SYNOVIS MICRO COMPANIES ALLIANCE, INC | 2015-10-08 |
| 00699753450394 | Capiox® Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-02 |