DTM · Class II · 21 CFR 870.4260

FDA Product Code DTM: Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Under FDA product code DTM, arterial line blood filters for cardiopulmonary bypass are cleared to remove particulate and gaseous emboli from the arterial perfusion line.

These microporous filters are placed in the arterial line of the heart-lung machine to capture microemboli — including air bubbles, fat particles, and cellular debris — before they enter the patient's circulation, reducing the risk of stroke and organ injury during cardiac surgery.

DTM devices are Class II medical devices, regulated under 21 CFR 870.4260 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Sorin Group Italia S.R.L., Bentley Laboratories, Inc. and American Bentley.

96
Total
96
Cleared
99d
Avg days
1978
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 145d recently vs 98d historically

FDA 510(k) Cleared Filter, Blood, Cardiopulmonary Bypass, Arterial Line Devices (Product Code DTM)

96 devices
1–24 of 96
Cleared Jan 16, 2026
Affinity Pixie™ Arterial Filter with Balance™ Biosurface
K251744
Medtronic
Cardiovascular · 224d
Cleared Dec 20, 2024
KIDS Arterial Filters
K242953
Sorin Group Italia S.R.L.
Cardiovascular · 86d
Cleared Nov 18, 2024
MICRO Arterial Filters
K242092
Sorin Group Italia S.R.L.
Cardiovascular · 124d
Cleared Oct 31, 2023
OCS Heart Leukocyte Depleting Filter
K231362
TransMedics, Inc.
Cardiovascular · 173d
Cleared Dec 07, 2012
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
K122760
Medtronic, Inc.
Cardiovascular · 88d
Cleared Dec 16, 2010
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
K100646
Medtronic, Inc.
Cardiovascular · 286d
Cleared Jan 22, 2010
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
K093986
Sorin Group Italia S.R.L.
Cardiovascular · 29d
Cleared Dec 18, 2009
QUART ARTERIAL FILTER WITH SOFTLINE COATING
K090518
Maquet Cardiopulmonary, AG
Cardiovascular · 295d
Cleared Dec 18, 2009
AF 840 PH.I.S.I.O. ARTERIAL FILTER
K093601
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Aug 20, 2009
TERUMO PALL AL3X ARTERIAL FILTER
K083747
Terumo Cardiovascular Systems Corp.
Cardiovascular · 246d
Cleared Apr 17, 2009
TERUMO PALL AL6X ARTERIAL FILTER
K083834
Terumo Cardiovascular Systems Corp.
Cardiovascular · 115d
Cleared Jan 15, 2009
GISH ARTERIAL FILTER WITH HA COATING
K081054
Gish Biomedical, Inc.
Cardiovascular · 276d
Cleared Oct 03, 2008
QUART ARTERIAL FILTER WITH BIOLINE COATING
K082544
Maquet Cardiopulmonary, AG
Cardiovascular · 30d
Cleared Sep 12, 2007
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED
K072308
Sorin Group Italia S.R.L.
Cardiovascular · 26d
Cleared Jul 03, 2007
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
K071253
Medtronic Vascular
Cardiovascular · 60d
Cleared Jan 11, 2007
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
K063255
Sorin Group Italia S.R.L.
Cardiovascular · 76d
Cleared Jun 20, 2006
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
K061546
Maquet Cardiopulmonary, AG
Cardiovascular · 15d
Cleared Sep 12, 2005
CAPIOX AF125X ARTERIAL FILTER
K052205
Terumo Cardiovascular Systems Corp.
Cardiovascular · 31d
Cleared Feb 26, 2004
DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
K040184
Cobe Cardiovascular, Inc.
Cardiovascular · 31d
Cleared Nov 03, 2003
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
K031946
Edwards Lifesciences, LLC
Cardiovascular · 132d
Cleared Aug 01, 2003
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
K032128
Terumo Cardiovascular Systems Corp.
Cardiovascular · 22d
Cleared Mar 31, 2003
GISH ARTERIAL FILTER WITH GBS COATING
K023833
Gish Biomedical, Inc.
Cardiovascular · 133d
Cleared Jul 09, 2001
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
K011804
Terumo Cardiovascular Systems Corp.
Cardiovascular · 28d
Cleared Nov 30, 2000
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
K002493
Cobe Cardiovascular, Inc.
Cardiovascular · 108d

About Product Code DTM - Regulatory Context

510(k) Submission Activity

96 total 510(k) submissions under product code DTM since 1978, with 96 receiving FDA clearance (average review time: 99 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DTM Product Code

Recent submissions under DTM have taken an average of 145 days to reach a decision - up from 98 days historically. Manufacturers should account for longer review timelines in current project planning.

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