Atlas FDA

DTM

96 FDA 510(k) clearances · Product code

70 daysmedian time to decision
244 days90th percentile
96clearances measured

FDA profile

Official device name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4260
Medical specialty
Cardiovascular
Flags
Life-sustaining
Adverse events (MAUDE)
2013: 9 · 2014: 64 · 2015: 34 · 2016: 27 · 2017: 15 · 2018: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter (K251744)Medtronic2026-01-16
KIDS Arterial Filters (K242953)Sorin Group Italia S.R.L.2024-12-20
MICRO Arterial Filters (K242092)Sorin Group Italia S.R.L.2024-11-18
OCS Heart Leukocyte Depleting Filter (K231362)TransMedics, Inc.2023-10-31
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE (K123351)Medtronic Perfusion Systems2013-03-19
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE (K122760)Medtronic, Inc.2012-12-07
TERUMO PALL AL20X ARTERIAL FILTER (K121209)Terumo Cardiovascular Systems Corporation2012-05-08
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS (K112525)Parexel International2011-09-29
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE (K100646)Medtronic, Inc.2010-12-16
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS (K093986)Sorin Group Italia S.R.L.2010-01-22
QUART ARTERIAL FILTER WITH SOFTLINE COATING (K090518)Maquet Cardiopulmonary, AG2009-12-18
AF 840 PH.I.S.I.O. ARTERIAL FILTER (K093601)Sorin Group Italia S.R.L.2009-12-18
TERUMO PALL AL3X ARTERIAL FILTER (K083747)Terumo Cardiovascular Systems Corp.2009-08-20
TERUMO PALL AL6X ARTERIAL FILTER (K083834)Terumo Cardiovascular Systems Corp.2009-04-17
GISH ARTERIAL FILTER WITH HA COATING (K081054)Gish Biomedical, Inc.2009-01-15
QUART ARTERIAL FILTER WITH BIOLINE COATING (K082544)Maquet Cardiopulmonary, AG2008-10-03
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED (K072308)Sorin Group Italia S.R.L.2007-09-12
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 (K071253)Medtronic Vascular2007-07-03
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED (K063255)Sorin Group Italia S.R.L.2007-01-11
MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH (K062429)Edwards Lifesciences Research Medical2006-09-27
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 (K061546)Maquet Cardiopulmonary, AG2006-06-20
D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER (K052717)Dideco S.R.L.2005-10-20
CAPIOX AF125X ARTERIAL FILTER (K052205)Terumo Cardiovascular Systems Corp.2005-09-12
D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER (K051232)Dideco S.R.L.2005-05-20
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS (K041061)Dideco S.P.A.2004-05-06
DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER (K040184)Cobe Cardiovascular, Inc.2004-02-26
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS (K033987)Dideco S.P.A.2004-01-08
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE (K033468)Medtronic Perfusion Systems2003-11-14
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE (K031946)Edwards Lifesciences, LLC2003-11-03
TERUMO AL8X ARTERIAL FILTER WITH X-COATING (K032128)Terumo Cardiovascular Systems Corp.2003-08-01
DBT, DYNAMIC BUBBLE TRAP (K031323)Convergenza AG2003-08-01
GISH ARTERIAL FILTER WITH GBS COATING (K023833)Gish Biomedical, Inc.2003-03-31
EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 (K022071)Embol-X, Inc.2003-02-14
AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T (K013084)Medtronic Perfusion Systems2001-09-27
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X (K011804)Terumo Cardiovascular Systems Corp.2001-07-09
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER (K002493)Cobe Cardiovascular, Inc.2000-11-30
CAPIOX ARTERIAL FILTER (K002026)Terumo Medical Corp.2000-09-06
QUART ARTERIAL FILTER, MODEL HBF 140 (K001787)Jostra Medizintechnik AG2000-06-30
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 (K001138)Medtronic Vascular2000-04-27
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352 (K000379)Medtronic Vascular2000-02-16
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 (K994208)Medtronic Perfusion Systems2000-01-13
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD (K982254)Cobe Cardiovascular, Inc.1998-09-10
PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE (K980762)Pall Corp.1998-09-01
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 (K961869)Sorin Biomedical, Inc.1996-08-12
AFFINITY ARTERIAL BLOOD FILTER (K952532)Avecor Cardiovascular, Inc.1995-10-06
DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN (K952270)Sorin Biomedical, Inc.1995-08-21
CAPIOX ARTERIAL FILTER (K943917)Terumo Medical Corp.1995-07-25
DIDECO PEDIATRIC ARTERIAL FILTERS (K945198)Sorin Biomedical, Inc.1995-06-27
MEDTRONIC ARTERIAL FILTER (K926413)Medtronic Vascular1993-08-24
GISH ARTERIAL FILTER (K914791)Gish Biomedical, Inc.1993-04-06
SHILEY PERFUSION TUBING SETS (K920594)Shiley, Inc.1993-03-18
MODIFIED PYROGEN TESTING (K910935)Electromedics, Inc.1991-05-16
ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 (K902723)Electromedics, Inc.1990-12-13
LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE (K902518)Pall Biomedical Products Co.1990-10-16
HEPARINIZED ARTERIAL SCREEN BLOOD FILTER (K900758)Cobe Laboratories, Inc.1990-05-17
MODIFIED GELMAN ARTERIAL FILTER (K892387)Gelman Sciences, Inc.1989-06-22
EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 (K882137)Medtronic Blood Systems, Inc.1988-08-12
BUBBLE TRAP-FILTER CAT. NO B180F37 (K873316)American Omni Medical, Inc.1988-07-14
MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER (K880671)Medtronic Blood Systems, Inc.1988-05-06
AIR VENT LINE CAT. NO. AVL-36 (K875080)American Omni Medical, Inc.1988-02-29
ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING (K864262)Johnson & Johnson Professionals, Inc.1987-01-02
INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 (K862609)Medical, Inc.1986-09-04
INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 (K862591)Medical, Inc.1986-09-04
GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) (K862068)Gelman Sciences, Inc.1986-08-08
SWANK ARTERIAL LINE BLOOD FILTER HF6000 (K855066)Cobe Laboratories, Inc.1986-02-26
PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE (K853987)Pall Biomedical Products Co.1985-12-11
ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX (K851003)Gish Biomedical, Inc.1985-07-29
HEPARIN COATED ARTERIAL BLOOD FILTERS (K842813)American Bentley1985-01-08
PALL EC PLUS FILTER W/FILTER SLEEVE (K834382)Pall Biomedical Products Co.1984-08-03
PALL EC PLUS FILTER (K834380)Pall Biomedical Products Co.1984-08-03
PEDIATRIC ARTERIAL BLOOD FILTER (K840612)American Bentley1984-04-17
LOW TRAUMA ARTERIAL FILTER H-640 (K831507)C.R. Bard, Inc.1983-12-29
INTERSEPT 40 MICRON FILTER W/TUBING (K833476)Extracorporeal Medical Specialities, Inc.1983-12-27
INTERSEPT 40 MICRON FILTER (K833477)Extracorporeal Medical Specialities, Inc.1983-12-27
PURGES LINES, PL-45 & PL-33 (K833048)American Bentley1983-10-20
ARTERIAL BLOOD FILTER AF-1025-AF-1025BL (K830131)American Bentley1983-01-28
ARTERIAL BLOOD FILTER AF-1040-AF-1040BL (K830132)American Bentley1983-01-28
INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT (K823108)Extracorporeal Medical Specialities, Inc.1982-11-30
INTERFACE ARTERIAL BLOOD FILTER #40 (K823258)Medical, Inc.1982-11-24
ARTERIAL BLOOD FILTER, #AF-1025 (K820044)Bentley Laboratories, Inc.1982-06-29
PEDIATRIC ARTERIAL BLOOD FILTER #AF-540 (K820679)Bentley Laboratories, Inc.1982-06-17
ARTERIAL BLOOD FILTER MODEL #AF-1040 (K820343)Bentley Laboratories, Inc.1982-06-17
WILLIAM HARVEY H-625 ARTERIAL FILTER (K820472)C.R. Bard, Inc.1982-03-15
CARDIOVASCULAR DEVICES (K820045)Bentley Laboratories, Inc.1982-01-29
TERUMO HOLLOW OXYGENATOR CIRCUIT (K812659)Terumo Medical Corp.1981-12-14
INTERFACE ARTERIAL BLOOD FILTER (K813131)Medical, Inc.1981-11-27
SHILEY ARTERIAL FILTER W/40 MICRON SCREE (K812742)Shiley, Inc.1981-11-02
SHILEY ARTERIAL FILTER (K811379)Shiley, Inc.1981-06-09
PEDIATRIC ARTERIAL BLOOD FILTER (K810068)Delta Medical Industries1981-01-22
ARTERIAL BLOOD FILTER BF-37 (K802755)Delta Medical Industries1981-01-07
L-3 PURGE LINE (K802602)Delta Medical Industries1980-11-12
PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 (K801147)Bentley Laboratories, Inc.1980-06-04
ARTERIAL BLOOD FILTER, MODEL AF-10 (K792450)Bentley Laboratories, Inc.1979-12-19
ULTIPOR BLOOD FILTER EXTRA-CORPOREAL (K791748)Pall Biomedical Products Co.1979-10-02
INTERSEPT* BLOOD FILTER W/ TUBING BYPASS (K790435)Surgikos, Inc.1979-03-27
FILTER, ARTERIAL BLOOD W/TUBING BYPASS (K781707)Surgikos, Inc.1978-10-26

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