Atlas FDA

DTN

169 FDA 510(k) clearances · Product code

79 daysmedian time to decision
242 days90th percentile
169clearances measured

FDA profile

Official device name
Reservoir, Blood, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4400
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2012: 17 · 2013: 47 · 2014: 52 · 2015: 27 · 2021: 12 · 2026: 55
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Inspire HCR and HCR DUAL cardiotomy reservoirs (K251783)Sorin Group Italia S.R.L.2025-12-22
Quantum Perfusion Hybrid System (K241206)Spectrum Medical S.R.L.2024-07-18
MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL (K241053)Medtronic Cardiac Surgery2024-05-15
BMR 1900 PHISIO (K223361)Sorin Group Italia S.R.L.2023-06-10
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (K170583)Medtronic, Inc.2017-03-17
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (K161733)Sorin Group Italia S.R.L.2017-03-08
Capiox Advance Hardshell Reservoir (K153143)Terumo Cardiovascular Systems Corporation2015-12-02
Intersept Filtered Cardiotomy Reservoir (K151110)Medtronic, Inc.2015-05-27
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH (K141432)Maquet Cardiopulmonary, AG2014-07-07
AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE (K141233)Medtronic, Inc.2014-06-12
INITARY BETTER BLADDER-PEDIATRIC (K140321)Circulatory Technology, Inc.2014-04-17
VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT (K132166)Maquet Cardiopulmonary, AG2013-10-30
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE (K132972)Medtronic, Inc.2013-10-28
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR (K131103)Sorin Group Italia S.R.L.2013-06-06
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE (K122914)Medtronic, Inc.2013-01-09
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG (K112771)Sorin Group Italia S.R.L.2011-10-14
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE (K102919)Maquet Cardiopulmonary, AG2011-03-11
XRES BLOOD COLLECTION RESERVOIR (K100507)Sorin Group Italia S.R.L.2010-03-24
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING (K090690)Maquet Cardiopulmonary, AG2009-12-23
VENOUS HARDSHELL CARDIOTOMY RESERVIORS (K090534)Maquet Cardiopulmonary, AG2009-12-23
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR (K092315)Sorin Group Italia S.R.L.2009-08-12
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 (K091062)Gish Biomedical, Inc.2009-08-04
MEDOS HILITE RESERVOIR, MODEL: 4030 (K083131)Gish Biomedical, Inc.2009-07-30
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING (K082082)Gish Biomedical, Inc.2009-02-04
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING (K081947)Gish Biomedical, Inc.2009-02-04
JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING (K070605)Maquet Cardiopulmonary, AG2008-01-04
3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES (K072697)3t Medical Systems, LLC2007-12-20
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR (K070839)Terumo Cardiovascular Systems Corp.2007-04-24
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 (K061743)Maquet Cardiopulmonary, AG2006-07-21
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING (K061527)Sorin Group Italia S.R.L.2006-06-27
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING (K051606)Gish Biomedical, Inc.2005-08-12
V-BAG WITH GBS COATING (K050195)Gish Biomedical, Inc.2005-03-17
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG (K050111)Cobe Cardiovascular, Inc.2005-03-08
CAPIOX FLEXIBLE VENOUS RESERVOIR (K040023)Terumo Cardiovascular Systems Corp.2004-03-01
CAPIOX CARDIOTOMY RESERVOIR (K033800)Terumo Cardiovascular Systems Corporation2004-02-10
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING (K033714)Dideco S.P.A.2003-12-11
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 (K033641)Cobe Cardiovascular, Inc.2003-12-11
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 (K031700)Medtronic Perfusion Systems2003-08-29
HEMOBAG, MODEL HBBSD2000 (K031150)Global Blood Resources, LLC2003-06-23
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING (K030726)Gish Biomedical, Inc.2003-05-30
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING (K024065)Gish Biomedical, Inc.2003-03-05
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR (K030449)Terumo Corp.2003-03-05
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 (K022281)Polystan A/S2002-08-06
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT (K021287)Medtronic Perfusion Systems2002-05-07
CAPIOX RX HARDSHELL RESERVOIR (K013526)Terumo Cardiovascular Systems Corp.2001-11-15
THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 (K012942)Circulatory Technology, Inc.2001-11-05
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 (K003551)Jostra AG2001-07-11
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B (K011864)Medtronic Vascular2001-07-09
MODEL 4815 ADAPTER (K002496)Pace Medical2000-10-10
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING (K002238)Terumo Cardiovascular Systems Corp.2000-08-22
THE V-BAG (K001822)Circulatory Technology, Inc.2000-07-07
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) (K001602)Dideco S.P.A.2000-06-08
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED (K994389)Cobe Cardiovascular, Inc.2000-03-27
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED (K993001)Cobe Cardiovascular, Inc.1999-12-03
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR (K992599)Dideco S.P.A.1999-11-01
CAPIOX SX10 HARDSHELL RESEVOIR (K991973)Terumo Medical Corp.1999-09-03
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS (K984586)Fresenius Hemotechnology, Inc.1999-06-29
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K990239)Cobe Cardiovascular, Inc.1999-05-25
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 (K982136)Schiff & Co.1999-03-24
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K984456)Cobe Cardiovascular, Inc.1999-01-11
CAPIOX SX HARDSHELL RESEVOIR (K982223)Terumo Medical Corp.1998-09-10
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 (K980786)Cobe Cardiovascular, Inc.1998-08-24
BETTER-BLADDER (BB) (K981284)Circulatory Technology, Inc.1998-08-12
BARD QUANTUM SVR MODEL NUMBER H-6440VR (K981628)C.R. Bard, Inc.1998-08-05
CAPIOX SX HARDSHELL RESERVOIR (K980935)Terumo Medical Corp.1998-05-14
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT (K974155)Baxter Healthcare Corp1998-01-22
CHASE TEMPERATURE PROBE (K971013)Chase Medical, Inc.1997-10-28
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) (K972017)Minntech Corp.1997-09-10
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER (K964908)Sorin Biomedical, Inc.1997-09-03
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT (K964907)Sorin Biomedical, Inc.1997-08-21
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR (K971669)Cobe Cardiovascular, Inc.1997-07-23
MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM (K971105)Avecor Cardiovascular, Inc.1997-07-11
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR (K964973)Gish Biomedical, Inc.1997-03-10
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR (K961836)Medtronic Vascular1996-11-01
BIOCOR 200 HARDSHELL VENOUS RESERVIOR (K953821)Minntech Corp.1996-03-07
SOFT VENOUS RESERVOIR (K955046)Gish Biomedical, Inc.1996-01-11
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 (K945065)Sorin Biomedical, Inc.1995-05-19
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR (K941215)Sorin Biomedical, Inc.1995-05-10
AFFINITY CVR (K936003)Avecor Cardiovascular, Inc.1994-06-20
AFFINITY VENOUS RESERVIOR BAG (K935717)Avecor Cardiovascular, Inc.1994-05-10
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS (K934847)Sorin Biomedical, Inc.1994-04-15
SORIN BLOOD CARDIOPLEGIA SYSTEM (K934763)Sorin Biomedical, Inc.1994-04-15
SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS (K936183)Sorin Biomedical, Inc.1994-03-23
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT (K933713)Baxter Healthcare Corp1994-03-01
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) (K936286)Gish Biomedical, Inc.1994-02-14
SORIN MONOLYTH VENOUS RESERVOIR (K933481)Sorin Biomedical, Inc.1993-11-02
EL2-SERIES BLOOD COLLECTION REERVOIR (K930154)Electromedics, Inc.1993-07-01
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET (K930299)C.R. Bard, Inc.1993-06-22
CARDIOTOMY RESERVOIR W/20 MICRON FILITER (K920178)Lifestream Int'L, Inc.1993-05-13
PLEUR-EVAC CARDIOTOMY RESERVOIR (K925046)Deknatel, Inc.1993-04-20
ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR (K926250)Electromedics, Inc.1993-02-19
VENOUS RESERVOIR W/CARDIOTOMY FILTER (K915573)Baxter Healthcare Corp1992-12-23
MVR COLLAPSIBLE VENOUS RESERVOIR BAG (K920774)Medtronic Vascular1992-10-19
NEW COBE CARDIOPLEGIA SYSTEM (K920312)Cobe Cardiovascular, Inc.1992-10-01
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR (K915737)Electromedics, Inc.1992-09-03
BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV (K913915)Bard Cardiosurgery Div1992-01-21
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 (K913956)Bentley Laboratories, Inc.1992-01-17
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) (K913692)Bentley Laboratories, Inc.1991-11-15
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG (K911790)Medtronic Vascular1991-08-12
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 (K911876)Shiley, Inc.1991-08-09
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