DPW — Flowmeter, Blood, Cardiovascular Class II
FDA product code DPW covers "Flowmeter, Blood, Cardiovascular", a Class II medical device regulated under 21 CFR 870.2100. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260700 | bluedop medical | BlueDop Vascular Expert | July 8, 2026 |
| K252810 | flosonics medical | FloPatch FP120 | April 24, 2026 |
| 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 |