Atlas FDA

Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter

FDA 510(k) clearance K251744 · decided 2026-01-16

Clearance details

K-number
K251744
Device name
Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter
Applicant
Medtronic
Decision
Substantially Equivalent
Date received
2025-06-06
Decision date
2026-01-16
Days to decision
224 days
Clearance type
Special
Product code
DTM
Device class
2
Regulation number
870.4260
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mounds View, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HeartWare HVAD System (P100047/S227)Medtronic2025-07-09
HeartWare­™ Ventricular Assist System (HVAD) (P100047/S230)Medtronic2025-06-26
HeartWare™ Ventricular Assist System (HVAD) (P100047/S229)Medtronic2025-06-05
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228)Medtronic2025-06-04
HeartWare HVAD System (P100047/S226)Medtronic2025-05-05
HeartWare® HVAD System (P100047/S225)Medtronic2025-04-24
HeartWare HVAD System (P100047/S224)Medtronic2025-04-02
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222)Medtronic2025-03-13