DTN · Class II · 21 CFR 870.4400

FDA Product Code DTN: Reservoir, Blood, Cardiopulmonary Bypass

Leading manufacturers include C.R. Bard, Inc., Medtronic Vascular and Medtronic, Inc..

169
Total
169
Cleared
109d
Avg days
1976
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 137d recently vs 108d historically

FDA 510(k) Cleared Reservoir, Blood, Cardiopulmonary Bypass Devices (Product Code DTN)

169 devices
1–24 of 169
Cleared Dec 22, 2025
Inspire HCR and HCR DUAL cardiotomy reservoirs
K251783
Sorin Group Italia S.R.L.
Cardiovascular · 194d
Cleared Jul 18, 2024
Quantum Perfusion Hybrid System
K241206
Spectrum Medical S.R.L.
Cardiovascular · 79d
Cleared May 15, 2024
MVR™ Venous Reservoir Bag 800 mL
K241053
Medtronic Cardiac Surgery
Cardiovascular · 28d
Cleared Jun 10, 2023
BMR 1900 PHISIO
K223361
Sorin Group Italia S.R.L.
Cardiovascular · 219d
Cleared Mar 17, 2017
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
K170583
Medtronic, Inc.
Cardiovascular · 17d
Cleared May 27, 2015
Intersept Filtered Cardiotomy Reservoir
K151110
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 12, 2014
AFFINITY PIXIE OXYGENATION SYSTEM WITH
K141233
Medtronic, Inc.
Cardiovascular · 30d
Cleared Oct 28, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
K132972
Medtronic, Inc.
Cardiovascular · 35d
Cleared Jan 09, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
K122914
Medtronic, Inc.
Cardiovascular · 110d
Cleared Jul 09, 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864
Medtronic Vascular
Cardiovascular · 25d
Cleared Aug 05, 1998
BARD QUANTUM SVR MODEL NUMBER H-6440VR
K981628
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Jan 22, 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
K974155
Baxter Healthcare Corp
Cardiovascular · 79d
Cleared Nov 01, 1996
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K961836
Medtronic Vascular
Cardiovascular · 172d
Cleared Mar 01, 1994
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
K933713
Baxter Healthcare Corp
Cardiovascular · 214d
Cleared Jun 22, 1993
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
K930299
C.R. Bard, Inc.
Cardiovascular · 152d
Cleared Dec 23, 1992
VENOUS RESERVOIR W/CARDIOTOMY FILTER
K915573
Baxter Healthcare Corp
Cardiovascular · 377d
Cleared Oct 19, 1992
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
K920774
Medtronic Vascular
Cardiovascular · 242d
Cleared Aug 12, 1991
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K911790
Medtronic Vascular
Cardiovascular · 112d
Cleared Dec 17, 1990
INTERSEPT 1375 VENOUS RESERVOIR
K903632
Medtronic Vascular
Cardiovascular · 129d
Cleared Dec 06, 1990
SOFTSHELL VENOUS RESERVOIR
K904040
C.R. Bard, Inc.
Cardiovascular · 93d
Cleared Mar 06, 1990
UNIVOX-IC
K895356
Baxter Healthcare Corp
Cardiovascular · 190d
Cleared Jan 31, 1990
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
K896414
Baxter Healthcare Corp
Cardiovascular · 84d
Cleared Sep 14, 1987
WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR
K872378
C.R. Bard, Inc.
Cardiovascular · 87d
Cleared Sep 29, 1986
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
K862920
C.R. Bard, Inc.
Cardiovascular · 59d

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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - DTN Product Code

Recent submissions under DTN have taken an average of 137 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 →