Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2100](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2100) → DPW — Flowmeter, Blood, Cardiovascular # DPW · Flowmeter, Blood, Cardiovascular _Cardiovascular · 21 CFR 870.2100 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW ## Overview - **Product Code:** DPW - **Device Name:** Flowmeter, Blood, Cardiovascular - **Regulation:** [21 CFR 870.2100](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2100) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K252810.md) | FloPatch FP120 | Flosonics Medical | Apr 24, 2026 | SESE | | [K251904](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K251904.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K251114.md) | FloPatch FP120 | Flosonics Medical | Jun 20, 2025 | SESE | | [K243852](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K243852.md) | Elfor-L | Elfi-Tech , Ltd. | Apr 14, 2025 | SESE | | [K241583](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K241583.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K223843.md) | FloPatch FP120 | Flosonics Medical | May 3, 2023 | SESE | | [K222242](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K222242.md) | FloPatch FP120 | Flosonics Medical | Dec 9, 2022 | SESE | | [K213974](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K213974.md) | GEM FLOW COUPLER Monitor (GEM1020M-2) | Synovis Micro Companies Alliance, Inc. | Apr 20, 2022 | SESE | | [K211589](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K211589.md) | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | Remington Medical, Inc. | Jan 27, 2022 | SESE | | [K212065](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K212065.md) | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | Remington Medical, Inc. | Oct 7, 2021 | SESE | | [K201114](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K201114.md) | Bidop 7 | Koven Technology, Inc. | Jan 5, 2021 | SESE | | [K200337](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K200337.md) | FloPatch (FP120) | Flosonics Medical (R/A 1929803 Ontario Corp.) | Mar 24, 2020 | SESE | | [K192966](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K192966.md) | FlowMet | Laser Associated Sciences, Inc. | Jan 10, 2020 | SESE | | [K183574](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K183574.md) | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Huntleigh Healthcare , Ltd. | Sep 6, 2019 | SESE | | [K191388](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K191388.md) | FloPatch (FP110) | Flosonics Medical (R/A 1929803 Ontario Corp.) | Jun 21, 2019 | SESE | | [K182494](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K182494.md) | FlowMet-R | Laser Associated Sciences, Inc. | Feb 27, 2019 | SESE | | [K181269](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K181269.md) | iCertainty | Rfpi | Dec 14, 2018 | SESE | | [K172457](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K172457.md) | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited | Jun 28, 2018 | SESE | | [K152930](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K152930.md) | PeriFlux6000 | Perimed AB | May 5, 2016 | SESE | | [K150268](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K150268.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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