Product Code: DTR FDA class 2 21 CFR 870.4240

Heat-Exchanger, Cardiopulmonary Bypass

Cardiovascular

The Cardiopulmonary Bypass Heat-Exchanger is a life-sustaining cardiovascular device used to regulate the temperature of blood as it passes through the extracorporeal circuit, enabling deliberate cooling and rewarming of the patient during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTR and it is regulated under 21 CFR 870.4240 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DTR in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DTR
Device Class: FDA class 2
Regulation Number: 870.4240
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 91 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252541	Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W	Mar 12, 2026	Substantially Equivalent	Spectrum Medical S.R.L.
K240908	Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)	Jul 08, 2025	Substantially Equivalent	Spectrum Medical , Ltd.
K250150	VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)	May 30, 2025	Substantially Equivalent	Sorin Group Italia S.R.L.
K240190	MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated	Feb 23, 2024	Substantially Equivalent	Medtronic
K223879	Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)	Apr 13, 2023	Substantially Equivalent	Quara S.R.L.
K220110	Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger	May 06, 2022	Substantially Equivalent	Qura S.R.L
K212688	Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger	Jan 10, 2022	Substantially Equivalent	Qura S.R.L
K201984	MPS 3 ND Myocardial Protection System	Nov 20, 2020	Substantially Equivalent	Quest Medical, Inc.
K200438	MPS 3 Myocardial Protection System	Jun 19, 2020	Substantially Equivalent	Quest Medical, Inc.
K173716	MPS2 Myocardial Protection System Console	Oct 01, 2018	Substantially Equivalent	Quest Medical, Inc.
K162774	MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)	Feb 10, 2017	Substantially Equivalent	Medtronic, Inc.
K162958	MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge	Feb 01, 2017	Substantially Equivalent	Medtronic, Inc.
K090555	PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30	Dec 23, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K081838	GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING	Jan 26, 2009	Substantially Equivalent	Gish Biomedical, Inc.
K072583	PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30	Apr 04, 2008	Substantially Equivalent	Maquet Cardiopulmonary, AG
K041979	MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260	Sep 02, 2004	Substantially Equivalent	Quest Medical, Inc.
K040355	VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING	Mar 15, 2004	Substantially Equivalent	Gish Biomedical, Inc.
K032068	CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200	Aug 22, 2003	Substantially Equivalent	Cardiovention, Inc.
K021830	SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM	Jul 02, 2002	Substantially Equivalent	Cobe Cardiovascular, Inc.
K020106	VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER	Apr 10, 2002	Substantially Equivalent	Gish Biomedical, Inc.
K012898	MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM	Sep 17, 2001	Substantially Equivalent	Cobe Cardiovascular, Inc.
K000977	COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS	Mar 23, 2001	Substantially Equivalent	Olson Medical Sales, Inc.
K003724	CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B	Dec 21, 2000	Substantially Equivalent	Medtronic Vascular
K991137	ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER	Jun 08, 2000	Substantially Equivalent	Minntech Corp.
K982467	CAPIOX CARDIOPLEGIA	Jun 23, 1999	Substantially Equivalent	Terumo Medical Corp.
K973475	CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)	Nov 20, 1997	Substantially Equivalent	Medtronic Vascular
K964571	VISION CARDIOPLEGIA DELIVERY SYSTEM	Aug 08, 1997	Substantially Equivalent	Lifestream Int'L, Inc.
K962320	S3 CARDIOPLEGIA CONTROL	Jan 10, 1997	Substantially Equivalent	Stoeckert Instrumente
K953838	MYOCARDIAL PROTECTION SYSTEM	Mar 06, 1996	Substantially Equivalent	Quest Medical, Inc.
K944219	SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS	Jun 30, 1995	Substantially Equivalent	Gish Biomedical, Inc.
K944267	HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA	Apr 28, 1995	Substantially Equivalent	Cobe Cardiovascular, Inc.
K934355	ELECTROMEDICS BLOOD HEAT EXCHANGER	Dec 03, 1993	Substantially Equivalent	Electromedics, Inc.
K932251	ROTATOR;MALE-MALE, MALE-FEMALE	Aug 05, 1993	Substantially Equivalent	Merit Medical Systems, Inc.
K931967	HE-30 GOLD	Jul 13, 1993	Substantially Equivalent	Bentley Laboratories, Inc.
K925369	BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS	Mar 26, 1993	Substantially Equivalent	Sorin Biomedica, Fiat, USA, Inc.
K923311	CONDUCER HEAT EXCHANGER	Sep 18, 1992	Substantially Equivalent	3M Health Care, Sarns
K913077	LANCASTER COOLING JACKET, CAT. CODE #13500/13501	Jan 09, 1992	Substantially Equivalent	Dlp, Inc.
K913691	CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES	Dec 18, 1991	Substantially Equivalent	Gish Biomedical, Inc.
K914742	MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF	Dec 04, 1991	Substantially Equivalent	Medtronic Vascular
K905500	MYOCARDIAL PROTECTION SYSTEM	Jun 10, 1991	Substantially Equivalent	Medtronic Vascular
K910923	BCD ADVANCED	Apr 09, 1991	Substantially Equivalent	Shiley, Inc.
K905568	TOPICAL COOLING PAD, MODEL 7000	Jan 23, 1991	Substantially Equivalent	Daily Medical Products, Inc.
K904171	SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM	Dec 06, 1990	Substantially Equivalent	Scimed
K896807	SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM	Jul 31, 1990	Substantially Equivalent	Gish Biomedical, Inc.
K896020	EXTRACORPOREAL HEAT EXCHANGER HE SERIES	May 17, 1990	Substantially Equivalent	Gish Biomedical, Inc.
K900640	MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU	Apr 20, 1990	Substantially Equivalent	3M Company
K897039	SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)	Mar 16, 1990	Substantially Equivalent	3M Company
K884560	SCIMED ECMOTHERM(TM) HEAT EXCHANGER	Apr 03, 1989	Substantially Equivalent	Scimed Life Systems, Inc.
K883071	SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM	Dec 05, 1988	Substantially Equivalent	3M Health Care, Sarns
K883439	INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM	Oct 13, 1988	Substantially Equivalent	Medtronic Blood Systems, Inc.
K883332	MAST FOR BASIC HEATER-COOLER UNIT 16-09-00	Sep 26, 1988	Substantially Equivalent	Shiley, Inc.
K883331	BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10	Sep 26, 1988	Substantially Equivalent	Shiley, Inc.
K883330	BASIC HEATER-COOLER UNIT, 115/100V 16-02-20	Sep 26, 1988	Substantially Equivalent	Shiley, Inc.
K880663	SHILEY BCD PLUS HEAT EXCHANGER	May 11, 1988	Substantially Equivalent	Shiley, Inc.
K880451	SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS	Apr 28, 1988	Substantially Equivalent	Scimed Life Systems, Inc.
K873561	ELECTROMEDICS D1079E	Nov 05, 1987	Substantially Equivalent	Electromedics, Inc.
K870804	CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100	Sep 01, 1987	Substantially Equivalent	American Bentley
K871774	CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS	Aug 03, 1987	Substantially Equivalent	Gish Biomedical, Inc.
K861102	CPS-3000 CARDIOPLEGIA RESERVOIR	May 28, 1986	Substantially Equivalent	Gish Biomedical, Inc.
K860920	STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL	May 21, 1986	Substantially Equivalent	Shiley, Inc.
K860523	CARDIO-COOL	Apr 29, 1986	Substantially Equivalent	Bio-Vascular, Inc.
K853791	NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000	Dec 09, 1985	Substantially Equivalent	Norton Performance Plastics Corp.
K853516	SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM	Nov 14, 1985	Substantially Equivalent	3M Health Care, Sarns
K853410	MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD	Oct 11, 1985	Substantially Equivalent	Intermedics, Inc.
K852780	BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)	Sep 30, 1985	Substantially Equivalent	Shiley, Inc.
K850794	PATIENT MONITOR MODEL RM-300	Apr 18, 1985	Substantially Equivalent	Honeywell, Inc.
K843983	MYOCARDIAL INSULATOR	Dec 27, 1984	Substantially Equivalent	Norton Texas Medical Products
K840256	CARDIOPLEGIA HEAT EXCHANGER HOLDER	Feb 17, 1984	Substantially Equivalent	American Bentley
K840045	CARDIOPLEGIA HEAT EXCHANGER HE-100	Feb 13, 1984	Substantially Equivalent	American Bentley
K833555	LAL TEST RELEASE & BONCHEK CAR/JACKET	Feb 04, 1984	Substantially Equivalent	Shiley, Inc.
K833662	CARDIOPLEGIA SYSTEM CCS-XXX SERIES	Dec 29, 1983	Substantially Equivalent	Gish Biomedical, Inc.
K832417	HYPOTHERMIC MYCARDIAL PROTECTION DEV	Oct 20, 1983	Substantially Equivalent	3M Health Care, Sarns
K831157	BLOOD CARDIOPLEGIA STAINLESS STEEL COOL	May 09, 1983	Substantially Equivalent	American Bentley
K823451	CLEAR CARDIOPLEJIA DELIVERY SYSTEM	Jan 14, 1983	Substantially Equivalent	3M Health Care, Sarns
K823533	JACKET & SET	Dec 30, 1982	Substantially Equivalent	Shiley, Inc.
K813264	D6ZO DISPOSABLE HEAT EXCHANGER	Jul 06, 1982	Substantially Equivalent	Electromedics, Inc.
K812093	COBE HEAT EXCHANGER RESERVOIR MODULE	Aug 13, 1981	Substantially Equivalent	Cobe Laboratories, Inc.
K811204	BRONCHEK-SHILEY CARDIAC JACKET & BSC J	May 21, 1981	Substantially Equivalent	Shiley, Inc.
K802545	CARDIOPLEGIC SETS	Jan 16, 1981	Substantially Equivalent	Texas Medical Products, Inc.
K802879	BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.	Dec 19, 1980	Substantially Equivalent	Shiley, Inc.
K802848	CARDIOPLEGIA COOLING SYST. CCAS-2	Dec 11, 1980	Substantially Equivalent	Bentley Laboratories, Inc.
K800717	TOPICAL COOLING DEV. TCD. #27-999	Apr 16, 1980	Substantially Equivalent	Cobe Laboratories, Inc.
K800377	CARDIOPLEGIA DELIVERY SYSTEM	Mar 19, 1980	Substantially Equivalent	3M Health Care, Sarns
K791430	MINIPRIME HYPOTHERMIC HEAT EXCHANGER	Aug 28, 1979	Substantially Equivalent	Travenol Laboratories, S.A.
K790756	HEAT EXCHANGER COIL	Jun 11, 1979	Substantially Equivalent	Delta Medical Industries
K781764	PAD, COOLING #27-999	Dec 04, 1978	Substantially Equivalent	Cobe Laboratories, Inc.
K781210	HEAT EXCHANGER, FHX-14	Oct 10, 1978	Substantially Equivalent	Delta Medical Industries
K772117	HEAT EXCHANGER, DISP., OMNITHERM	Mar 02, 1978	Substantially Equivalent	Scimed Life Systems, Inc.
K770018	PACING KIT, SEMI-FLOATING	Jan 14, 1977	Substantially Equivalent	Electro-Catheter Corp.
K770017	PACING KIT, TRANSMYOCARDIAL	Jan 14, 1977	Substantially Equivalent	Electro-Catheter Corp.
K770016	PACING KIT, ELECATH TRANSTHORACIC	Jan 14, 1977	Substantially Equivalent	Electro-Catheter Corp.