DPW — Flowmeter, Blood, Cardiovascular Class II
FDA Device Classification
Classification Details
- Product Code
- DPW
- Device Class
- Class II
- Regulation Number
- 870.2100
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251904 | remington medical | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake | November 20, 2025 |
| K251114 | flosonics medical | FloPatch FP120 | June 20, 2025 |
| K243852 | elfi-tech | Elfor-L | April 14, 2025 |
| K241583 | remington medical | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge | August 30, 2024 |
| K223843 | flosonics medical | FloPatch FP120 | May 3, 2023 |
| K222242 | flosonics medical | FloPatch FP120 | December 9, 2022 |
| K213974 | synovis micro companies alliance | GEM FLOW COUPLER Monitor (GEM1020M-2) | April 20, 2022 |
| K211589 | remington medical | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge | January 27, 2022 |
| K212065 | remington medical | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge | October 7, 2021 |
| K201114 | koven technology | Bidop 7 | January 5, 2021 |
| K200337 | flosonics medical (r/a 1929803 ontario corp.) | FloPatch (FP120) | March 24, 2020 |
| K192966 | laser associated sciences | FlowMet | January 10, 2020 |
| K183574 | huntleigh healthcare | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | September 6, 2019 |
| K191388 | flosonics medical (r/a 1929803 ontario corp.) | FloPatch (FP110) | June 21, 2019 |
| K182494 | laser associated sciences | FlowMet-R | February 27, 2019 |
| K181269 | rfpi | iCertainty | December 14, 2018 |
| K172457 | deltex medical limited | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | June 28, 2018 |
| K152930 | perimed | PeriFlux6000 | May 5, 2016 |
| K150268 | or-nim medical | CerOX | November 6, 2015 |
| K150347 | deltex medical limited | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ | July 24, 2015 |