DPW · Flowmeter, Blood, Cardiovascular
Cardiovascular · 21 CFR 870.2100 · Class 2
Overview
| Product Code | DPW |
|---|---|
| Device Name | Flowmeter, Blood, Cardiovascular |
| Regulation | 21 CFR 870.2100 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 137)
Showing 20 most recent of 137 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252810 | FloPatch FP120 | Flosonics Medical | Apr 24, 2026 | SESE |
| 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. | Nov 20, 2025 | SESE |
| K251114 | FloPatch FP120 | Flosonics Medical | Jun 20, 2025 | SESE |
| K243852 | Elfor-L | Elfi-Tech , Ltd. | Apr 14, 2025 | SESE |
| 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. | Aug 30, 2024 | SESE |
| K223843 | FloPatch FP120 | Flosonics Medical | May 3, 2023 | SESE |
| K222242 | FloPatch FP120 | Flosonics Medical | Dec 9, 2022 | SESE |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | Synovis Micro Companies Alliance, Inc. | Apr 20, 2022 | SESE |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | Remington Medical, Inc. | Jan 27, 2022 | SESE |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | Remington Medical, Inc. | Oct 7, 2021 | SESE |
| K201114 | Bidop 7 | Koven Technology, Inc. | Jan 5, 2021 | SESE |
| K200337 | FloPatch (FP120) | Flosonics Medical (R/A 1929803 Ontario Corp.) | Mar 24, 2020 | SESE |
| K192966 | FlowMet | Laser Associated Sciences, Inc. | Jan 10, 2020 | SESE |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Huntleigh Healthcare , Ltd. | Sep 6, 2019 | SESE |
| K191388 | FloPatch (FP110) | Flosonics Medical (R/A 1929803 Ontario Corp.) | Jun 21, 2019 | SESE |
| K182494 | FlowMet-R | Laser Associated Sciences, Inc. | Feb 27, 2019 | SESE |
| K181269 | iCertainty | Rfpi | Dec 14, 2018 | SESE |
| K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited | Jun 28, 2018 | SESE |
| K152930 | PeriFlux6000 | Perimed AB | May 5, 2016 | SESE |
| K150268 | CerOX | Or-Nim Medical , Ltd. | Nov 6, 2015 | SESE |
Top Applicants
- Koven Technology, Inc. — 7 clearances
- Koven and Assoc., Inc. — 5 clearances
- Transonic Systems, Inc. — 5 clearances
- Cardio Metrics, Inc. — 4 clearances
- Deltex Medical Limited — 4 clearances
