Product Code: DRY FDA class 2 21 CFR 870.4330

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Cardiovascular

The On-Line Blood-Gas Monitor for Cardiopulmonary Bypass is a cardiovascular diagnostic device used during open-heart surgery to continuously measure arterial blood gas levels within the extracorporeal bypass circuit, enabling real-time management of oxygenation and ventilation. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRY and it is regulated under 21 CFR 870.4330 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: DRY
Device Class: FDA class 2
Regulation Number: 870.4330
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 47 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K234065	CDI OneView Monitoring System	Apr 25, 2024	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K202154	B-Capta	Apr 01, 2021	Substantially Equivalent	Livanova Deutschland, GmbH
K202557	Quantum Workstation 12 Elite	Oct 02, 2020	Substantially Equivalent	Spectrum Medical , Ltd.
K182110	CDI Blood Parameter Monitoring System 550	Nov 02, 2018	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K181923	Quantum Workstation 12.1	Aug 17, 2018	Substantially Equivalent	Spectrum Medical , Ltd.
K173591	Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas	Mar 28, 2018	Substantially Equivalent	Spectrum Medical , Ltd.
K163657	Quantum Workstation	Jan 18, 2017	Substantially Equivalent	Spectrum Medical , Ltd.
K133157	TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6	Oct 23, 2014	Substantially Equivalent	Medtronic, Inc.
K133658	CDI BLOOD PARAMETER MONITORING SYSTEM 500	Jul 25, 2014	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K123039	CDI BLOOD PARAMETER MONITORING SYSTEM 500	Nov 20, 2012	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K110957	M4 MONITOR	May 31, 2011	Substantially Equivalent	Spectrum Medical, Llp
K103168	B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)	Jan 06, 2011	Substantially Equivalent	Sorin Group Deutschland GmbH
K091908	M3 MONITOR	Jul 10, 2009	Substantially Equivalent	Spectrum Medical , Ltd.
K090147	BLOOD MONITORING UNIT, MODEL BMU 40	Apr 22, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K072131	M3 MONITOR	Aug 17, 2007	Substantially Equivalent	Spectrum Medical , Ltd.
K071725	M2 MONITOR	Jul 11, 2007	Substantially Equivalent	Spectrum Medical , Ltd.
K062468	SPECTRUM M2 MONITOR	Sep 13, 2006	Substantially Equivalent	Spectrum Medical, Llp
K012743	TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T	Sep 14, 2001	Substantially Equivalent	Medtronic Perfusion Systems
K001388	DATA MASTER PERFUSION MONITORING SYSTEM	Jul 28, 2000	Substantially Equivalent	Dideco
K980732	3M CDI QUICK-CELLS WITH HEPARIN TREATMENT	May 15, 1998	Substantially Equivalent	3M Healthcare
K973472	3M CDI H/S CUVETTES WITH HEPARON TREATMENT	Dec 08, 1997	Substantially Equivalent	3M Healthcare
K972962	3M CDI BLOOD PARAMETER MONITORING SYSTEM 500	Nov 06, 1997	Substantially Equivalent	3M Company
K955380	IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)	May 14, 1996	Substantially Equivalent	International Biophysics Corp.
K955379	IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)	May 14, 1996	Substantially Equivalent	International Biophysics Corp.
K941922	MEDSAT OXYGEN SATURATION SYSTEM	Feb 17, 1995	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K931968	CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO	Nov 10, 1993	Substantially Equivalent	3M Health Care, Ltd.
K915265	CDI(TM) H/S CUVETTE, MODIFICATION	Jan 15, 1992	Substantially Equivalent	3M Company
K915255	CDI(TM) 300, 400 & 100, MODIFICATION	Jan 15, 1992	Substantially Equivalent	3M Company
K910421	SATURATION/HEMATOCRIT MONITOR SYSTEM	Oct 15, 1991	Substantially Equivalent	Medtronic Vascular
K903729	GOLD GATORS	Sep 14, 1990	Substantially Equivalent	Lead-Lok, Inc.
K900682	PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE	Jul 31, 1990	Substantially Equivalent	Contour Electrodes, Inc.
K900459	APPLICARD (EKG)	Jul 31, 1990	Substantially Equivalent	Medi-Globe Corp.
K881006	STOCKERT-SHILEY BUBBLE MONITOR 23-23-01	May 24, 1988	Substantially Equivalent	Shiley, Inc.
K874839	STAT-SAT	May 13, 1988	Substantially Equivalent	Gish Biomedical, Inc.
K871686	GEM-CRIT CHECK	Jun 18, 1987	Substantially Equivalent	Diamond Sensor Systems
K871221	CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300	Jun 05, 1987	Substantially Equivalent	Cardiovascular Devices, Inc.
K862953	CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE	Aug 25, 1986	Substantially Equivalent	Classic Medical Products, Inc.
K862069	CARDIOMET 4000 GAS MONITORING SYSTEMS	Jul 18, 1986	Substantially Equivalent	Biomedical Sensors, Inc.
K861277	CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000	Jun 02, 1986	Substantially Equivalent	Critichem, Inc.
K854357	GEM-6, WITH COMPONENTS	Jan 08, 1986	Substantially Equivalent	Diamond Electro-Tech, Inc.
K852124	HEMATOCRIT-SATURATION MONITOR HSM-100	Sep 16, 1985	Substantially Equivalent	American Bentley
K843709	COBE SATURATION CELL	Oct 24, 1984	Substantially Equivalent	Cobe Laboratories, Inc.
K843538	PO 2 LYTRODE	Oct 18, 1984	Substantially Equivalent	Polystan C/O Vitalcor, Inc.
K831225	GAS-STAT MONITORING SYSTEM	May 27, 1983	Substantially Equivalent	Cardiovascular Devices, Inc.
K823359	OXYGEN CONSUMPTION MONITOR #OCM-0100	Jan 05, 1983	Substantially Equivalent	Bentley Laboratories, Inc.
K821159	IN-LINE OXYGEN MONITORING SYSTEM	May 25, 1982	Substantially Equivalent	G.D. Searle and Co.
K811391	OXIMETRIX ACCU SAT CPB	Jul 20, 1981	Substantially Equivalent	Oximetrix, Inc.