Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4330](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4330) → DRY — Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass # DRY · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass _Cardiovascular · 21 CFR 870.4330 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY ## Overview - **Product Code:** DRY - **Device Name:** Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass - **Regulation:** [21 CFR 870.4330](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4330) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 47) Showing 20 most recent of 47 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K234065](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K234065.md) | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation | Apr 25, 2024 | SESE | | [K202154](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K202154.md) | B-Capta | Livanova Deutschland, GmbH | Apr 1, 2021 | SESE | | [K202557](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K202557.md) | Quantum Workstation 12 Elite | Spectrum Medical , Ltd. | Oct 2, 2020 | SESE | | [K182110](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K182110.md) | CDI Blood Parameter Monitoring System 550 | Terumo Cardiovascular Systems Corporation | Nov 2, 2018 | SESE | | [K181923](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K181923.md) | Quantum Workstation 12.1 | Spectrum Medical , Ltd. | Aug 17, 2018 | SESE | | [K173591](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K173591.md) | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical , Ltd. | Mar 28, 2018 | SESE | | [K163657](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K163657.md) | Quantum Workstation | Spectrum Medical , Ltd. | Jan 18, 2017 | SESE | | [K133157](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K133157.md) | TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 | Medtronic, Inc. | Oct 23, 2014 | SESE | | [K133658](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K133658.md) | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | Jul 25, 2014 | SESE | | [K123039](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K123039.md) | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | Nov 20, 2012 | SESE | | [K110957](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K110957.md) | M4 MONITOR | Spectrum Medical, Llp | May 31, 2011 | SESE | | [K103168](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K103168.md) | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) | Sorin Group Deutschland GmbH | Jan 6, 2011 | SESE | | [K091908](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K091908.md) | M3 MONITOR | Spectrum Medical , Ltd. | Jul 10, 2009 | SESE | | [K090147](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K090147.md) | BLOOD MONITORING UNIT, MODEL BMU 40 | Maquet Cardiopulmonary, AG | Apr 22, 2009 | SESE | | [K072131](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K072131.md) | M3 MONITOR | Spectrum Medical , Ltd. | Aug 17, 2007 | SESE | | [K071725](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K071725.md) | M2 MONITOR | Spectrum Medical , Ltd. | Jul 11, 2007 | SESE | | [K062468](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K062468.md) | SPECTRUM M2 MONITOR | Spectrum Medical, Llp | Sep 13, 2006 | SESE | | [K012743](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K012743.md) | TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T | Medtronic Perfusion Systems | Sep 14, 2001 | SESE | | [K001388](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K001388.md) | DATA MASTER PERFUSION MONITORING SYSTEM | Dideco | Jul 28, 2000 | SESE | | [K980732](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K980732.md) | 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT | 3M Healthcare | May 15, 1998 | SESE | ## Top Applicants - Spectrum Medical , Ltd. — 7 clearances - 3M Company — 3 clearances - 3M Healthcare — 2 clearances - Cardiovascular Devices, Inc. — 2 clearances - International Biophysics Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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