Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2770](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2770) → DSB — Plethysmograph, Impedance # DSB · Plethysmograph, Impedance _Cardiovascular · 21 CFR 870.2770 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB ## Overview - **Product Code:** DSB - **Device Name:** Plethysmograph, Impedance - **Regulation:** [21 CFR 870.2770](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2770) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. ## Classification Rationale Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Special Controls *Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Recent Cleared Devices (20 of 114) Showing 20 most recent of 114 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250634](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K250634.md) | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | Nov 24, 2025 | SESE | | [K243727](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K243727.md) | Re:Balans | Mode Sensors AS | Oct 16, 2025 | SESE | | [K250922](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K250922.md) | Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical , Ltd. | Sep 9, 2025 | SESE | | [K232089](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K232089.md) | SOZO Pro | ImpediMed Limited | Oct 17, 2023 | SESE | | [K223217](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K223217.md) | Zynex Monitoring System, Model CM-1600 | Zynex Medical, Inc. | Jun 16, 2023 | SESE | | [K211585](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K211585.md) | Bodyport Cardiac Scale | Bodyport, Inc. | Jul 29, 2022 | SESE | | [K203473](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K203473.md) | SOZO | ImpediMed Limited | Apr 19, 2021 | SESE | | [K193410](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K193410.md) | SOZO Body Fluid Analyzer | ImpediMed Limited | Oct 2, 2020 | SESE | | [K191697](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K191697.md) | Cardiac Monitor 1500 | Zynex Medical, Inc. | Feb 21, 2020 | SESE | | [K180479](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K180479.md) | ReDS System | Sensible Medical Innovations , Ltd. | Feb 28, 2019 | SESE | | [K172431](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K172431.md) | Cardiovascular Analzyer | Physiowave, Inc. | Mar 14, 2018 | SESE | | [K172507](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K172507.md) | SOZO | ImpediMed Limited | Dec 22, 2017 | SESE | | [K172196](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K172196.md) | ECOM™ Cardiac Output Monitoring System | Ecom Medical, Inc. | Sep 19, 2017 | SESE | | [K150095](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K150095.md) | ReDs Wearable System | Sensible Medical Innovations , Ltd. | Aug 6, 2015 | SESE | | [K142503](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K142503.md) | IMED-Z FLUID STATUS MONITOR | Intersection Medical, Inc. | Jun 5, 2015 | SESE | | [K140102](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K140102.md) | PHYSIOFLOW Q-LINK | Vasocom, Inc. | Feb 12, 2014 | SESE | | [K133301](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K133301.md) | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, Inc. | Jan 22, 2014 | SESE | | [K131765](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K131765.md) | ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM | Conmed Corporation | Dec 20, 2013 | SESE | | [K131509](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K131509.md) | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, Inc. | Jun 28, 2013 | SESE | | [K112830](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K112830.md) | ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) | Noninvasive Medical Technologies, Inc. | Nov 13, 2012 | SESE | ## Top Applicants - Cardiodynamics International Corp. — 11 clearances - Bomed Medical Mfr., Ltd. — 4 clearances - ImpediMed Limited — 4 clearances - Biodynamics Corp. — 3 clearances - Cardio Kinetics, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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