DTR · Class II · 21 CFR 870.4240

FDA Product Code DTR: Heat-exchanger, Cardiopulmonary Bypass

Leading manufacturers include Shiley, Inc., Gish Biomedical, Inc. and 3M Health Care, Sarns.

91
Total
91
Cleared
112d
Avg days
1977
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 268d recently vs 106d historically

FDA 510(k) Cleared Heat-exchanger, Cardiopulmonary Bypass Devices (Product Code DTR)

91 devices
1–24 of 91
Cleared Mar 12, 2026
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
K252541
Spectrum Medical S.R.L.
Cardiovascular · 212d
Cleared Jul 08, 2025
Quantum Micro-Cardioplegia Delivery System
K240908
Spectrum Medical , Ltd.
Cardiovascular · 462d
Cleared May 30, 2025
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)
K250150
Sorin Group Italia S.R.L.
Cardiovascular · 129d
Cleared Feb 23, 2024
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
K240190
Medtronic
Cardiovascular · 30d
Cleared Apr 13, 2023
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
K223879
Quara S.R.L.
Cardiovascular · 107d
Cleared May 06, 2022
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
K220110
Qura S.R.L
Cardiovascular · 113d
Cleared Jan 10, 2022
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
K212688
Qura S.R.L
Cardiovascular · 138d
Cleared Nov 20, 2020
MPS 3 ND Myocardial Protection System
K201984
Quest Medical, Inc.
Cardiovascular · 126d
Cleared Jun 19, 2020
MPS 3 Myocardial Protection System
K200438
Quest Medical, Inc.
Cardiovascular · 116d
Cleared Oct 01, 2018
MPS2 Myocardial Protection System Console
K173716
Quest Medical, Inc.
Cardiovascular · 300d
Cleared Feb 10, 2017
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)
K162774
Medtronic, Inc.
Cardiovascular · 130d
Cleared Feb 01, 2017
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface
K162958
Medtronic, Inc.
Cardiovascular · 100d
Cleared Dec 23, 2009
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
K090555
Maquet Cardiopulmonary, AG
Cardiovascular · 296d
Cleared Jan 26, 2009
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
K081838
Gish Biomedical, Inc.
Cardiovascular · 210d
Cleared Apr 04, 2008
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
K072583
Maquet Cardiopulmonary, AG
Cardiovascular · 204d
Cleared Sep 02, 2004
MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
K041979
Quest Medical, Inc.
Cardiovascular · 41d
Cleared Mar 15, 2004
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING
K040355
Gish Biomedical, Inc.
Cardiovascular · 32d
Cleared Jul 02, 2002
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
K021830
Cobe Cardiovascular, Inc.
Cardiovascular · 28d
Cleared Apr 10, 2002
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
K020106
Gish Biomedical, Inc.
Cardiovascular · 89d
Cleared Sep 17, 2001
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
K012898
Cobe Cardiovascular, Inc.
Cardiovascular · 19d
Cleared Dec 21, 2000
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
K003724
Medtronic Vascular
Cardiovascular · 17d
Cleared Jun 23, 1999
CAPIOX CARDIOPLEGIA
K982467
Terumo Medical Corp.
Cardiovascular · 343d
Cleared Nov 20, 1997
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
K973475
Medtronic Vascular
Cardiovascular · 69d
Cleared Mar 06, 1996
MYOCARDIAL PROTECTION SYSTEM
K953838
Quest Medical, Inc.
Cardiovascular · 203d

About Product Code DTR - Regulatory Context

510(k) Submission Activity

91 total 510(k) submissions under product code DTR since 1977, with 91 receiving FDA clearance (average review time: 112 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DTR Product Code

Recent submissions under DTR have taken an average of 268 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.

DTR devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →