FDA Product Code DTN: Reservoir, Blood, Cardiopulmonary Bypass
Leading manufacturers include Gish Biomedical, Inc., Shiley, Inc. and American Bentley.
169
Total
169
Cleared
109d
Avg days
1976
Since
Declining activity -
1 submissions in the last 2 years
vs 3 in the prior period
Review times increasing: avg
194d
recently vs 108d historically
FDA 510(k) Cleared Reservoir, Blood, Cardiopulmonary Bypass Devices (Product Code DTN)
169 devices
Cleared
Dec 22, 2025
Inspire HCR and HCR DUAL cardiotomy reservoirs
Sorin Group Italia S.R.L.
Cardiovascular
194d
Cleared
Jul 18, 2024
Quantum Perfusion Hybrid System
Spectrum Medical S.R.L.
Cardiovascular
79d
Cleared
May 15, 2024
MVR™ Venous Reservoir Bag 800 mL
Medtronic Cardiac Surgery
Cardiovascular
28d
Cleared
Jun 10, 2023
BMR 1900 PHISIO
Sorin Group Italia S.R.L.
Cardiovascular
219d
Cleared
Mar 17, 2017
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
Medtronic, Inc.
Cardiovascular
17d
Cleared
Mar 08, 2017
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
Sorin Group Italia S.R.L.
Cardiovascular
258d
Cleared
May 27, 2015
Intersept Filtered Cardiotomy Reservoir
Medtronic, Inc.
Cardiovascular
30d
Cleared
Jul 07, 2014
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
Maquet Cardiopulmonary, AG
Cardiovascular
38d
Cleared
Jun 12, 2014
AFFINITY PIXIE OXYGENATION SYSTEM WITH
Medtronic, Inc.
Cardiovascular
30d
Cleared
Oct 30, 2013
VENOUS HARDSHELL CARDIOTOMY RESERVOIR
Maquet Cardiopulmonary, AG
Cardiovascular
110d
Cleared
Oct 28, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
Medtronic, Inc.
Cardiovascular
35d
Cleared
Jun 06, 2013
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
Sorin Group Italia S.R.L.
Cardiovascular
48d
Cleared
Jan 09, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
Medtronic, Inc.
Cardiovascular
110d
Cleared
Oct 14, 2011
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
Sorin Group Italia S.R.L.
Cardiovascular
21d
Cleared
Mar 11, 2011
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
Maquet Cardiopulmonary, AG
Cardiovascular
161d
Cleared
Mar 24, 2010
XRES BLOOD COLLECTION RESERVOIR
Sorin Group Italia S.R.L.
Cardiovascular
30d
Cleared
Dec 23, 2009
VENOUS HARDSHELL CARDIOTOMY RESERVIORS
Maquet Cardiopulmonary, AG
Cardiovascular
299d
Cleared
Dec 23, 2009
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
Maquet Cardiopulmonary, AG
Cardiovascular
282d
Cleared
Aug 12, 2009
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
Sorin Group Italia S.R.L.
Cardiovascular
13d
Cleared
Aug 04, 2009
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
Gish Biomedical, Inc.
Cardiovascular
112d
Cleared
Jul 30, 2009
MEDOS HILITE RESERVOIR, MODEL: 4030
Gish Biomedical, Inc.
Cardiovascular
280d
Cleared
Feb 04, 2009
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
Gish Biomedical, Inc.
Cardiovascular
211d
Cleared
Feb 04, 2009
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
Gish Biomedical, Inc.
Cardiovascular
196d
Cleared
Jan 04, 2008
JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
Maquet Cardiopulmonary, AG
Cardiovascular
305d
About Product Code DTN - Regulatory Context
510(k) Submission Activity
169 total 510(k) submissions under product code DTN since 1976, with 169 receiving FDA clearance (average review time: 109 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - DTN Product Code
Recent submissions under DTN have taken an average of 194 days to reach a decision - up from 108 days historically. Manufacturers should account for longer review timelines in current project planning.
DTN devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →