Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2780](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2780) → JOM — Plethysmograph, Photoelectric, Pneumatic Or Hydraulic # JOM · Plethysmograph, Photoelectric, Pneumatic Or Hydraulic _Cardiovascular · 21 CFR 870.2780 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM ## Overview - **Product Code:** JOM - **Device Name:** Plethysmograph, Photoelectric, Pneumatic Or Hydraulic - **Regulation:** [21 CFR 870.2780](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2780) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 53) Showing 20 most recent of 53 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K220527](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K220527.md) | PADnet Xpress | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | Oct 20, 2022 | SESE | | [K213730](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K213730.md) | MESI mTABLET TBI diagnostic system, MESI mTABLET TBI | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | Apr 21, 2022 | SESE | | [K200567](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K200567.md) | ASI Plethysmogrpah Analyzer | Arterial Stiffness, Inc. | Feb 26, 2021 | SESE | | [K201046](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K201046.md) | Automated ankle brachial pressure index measuring device, MESI mTABLET system | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | Dec 11, 2020 | SESE | | [K191266](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K191266.md) | VitalScan ANS | Medeia, Inc. | Jan 15, 2020 | SESE | | [K172655](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K172655.md) | Automated ankle brachial pressure index measuring device | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | Jan 11, 2018 | SESE | | [K173696](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K173696.md) | TBL-ABI System | Ld Technology, LLC | Dec 19, 2017 | SESE | | [K143152](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K143152.md) | TM-ABI system | Ld Technology, LLC | Jul 22, 2015 | SESE | | [K143094](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K143094.md) | QuantaFlo | Semler Scientific, Inc. | Mar 5, 2015 | SESE | | [K123921](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K123921.md) | BODYTRONIC 200 | Bauerfeind AG | Apr 26, 2013 | SESE | | [K121108](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K121108.md) | DOPPLEX ABILITY | Huntleigh Healthcare | Jan 3, 2013 | SESE | | [K122281](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K122281.md) | PADNET 2.0 | Biomedix, Inc. | Aug 29, 2012 | SESE | | [K110374](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K110374.md) | MAX PULSE SYSTEM | Medicore Co., Ltd. | Jun 13, 2011 | SESE | | [K101983](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K101983.md) | CRITICAL CARE ASSESSMENT | Critical Patient Care, Inc. | Sep 21, 2010 | SESE | | [K093192](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K093192.md) | FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE | Advanced Vascular Dynamics | Feb 12, 2010 | SESE | | [K083735](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K083735.md) | ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS | Medtechs, LLC | Feb 18, 2009 | SESE | | [K073323](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K073323.md) | SA-3000P | Medicore Co., Ltd. | Nov 29, 2007 | SESE | | [K073146](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K073146.md) | PADNET+ | Biomedix, Inc. | Nov 21, 2007 | SESE | | [K042616](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K042616.md) | BIOMEDIX PADNET LAB | Biomedix, Inc. | Oct 12, 2004 | SESE | | [K023238](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K023238.md) | MCPULSE | Meridian Co., Ltd. | Feb 19, 2003 | SESE | ## Top Applicants - D. E. Hokanson, Inc. — 5 clearances - Biomedix, Inc. — 3 clearances - Ld Technology, LLC — 2 clearances - Life Sciences Manufacturing, Inc. — 2 clearances - Medasonics, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com