510(k) · Cleared

Recalled · Class II · 2013

Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface, Model CB4014

K071253510(k) TraditionalCleared Jul 3, 200760-day reviewClass II21 CFR 870.4260Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Vascular · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Cleared on Jul 3, 2007 as substantially equivalent to K943917 (Terumo Medical Corp., 1995) and 2 other predicates after a 60-day review. Its family tree reaches back 1 generation to 1995. 7 later devices descend from it. It has been recalled 2 times.

Decided: Jul 3, 2007
Review: 60 days
Class: Class II
Product code: DTM
Recalls: 2
Predicates: 3

Its longest line of descent runs back 1 generation to K943917 (1995). 3 ancestors in all. 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK943917 Capiox Arterial FilterTerumo Medical Corp. · 1995
This deviceK071253 Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda…Medtronic Vascular · 2007
Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
Descendant · 3 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
Descendant · 4 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
Descendant · 5 generations on · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011high 3 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 7 · See all

K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 2 generations on4descendants
K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 3 generations on2descendants
K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 4 generations on1descendant
K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943917	Capiox Arterial Filter	Terumo Medical Corp.	1995	—
0 (this device)	K071253	Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive…	Medtronic Vascular	2007	—
+1	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—
+2	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2
+3	K140165	MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…	Medtronic, Inc.	2014	—
+4	K251258	MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula	Medtronic, Inc.	2025	—
+5	K262052	Tri Stage Venous Cannulae	Sorin Group Italia S.R.L.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2014	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K071253, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DTM device

#1 K251744 Affinity Pixie™ Arterial Filter with Balance™…score 11.0 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K943917	Capiox Arterial Filter Summary page 1 …Regulation Number: 21 CFR 870.4260 Product Code: DTM Classification: Class LI Predicate Devices Terumo Capiox Arterial Filter, AF02, Pediatric (K943917) Medtronic Affinity® Arterial Filter (K952532) Medtronic Affinity® Arterial Filter, Carmeda® Coated (K000379) Device Descr…	Terumo Medical Corp.	1995	—
*	K952532	Affinity Arterial Blood Filter Summary page 1 …Code: DTM Classification: Class LI Predicate Devices Terumo Capiox Arterial Filter, AF02, Pediatric (K943917) Medtronic Affinity® Arterial Filter (K952532) Medtronic Affinity® Arterial Filter, Carmeda® Coated (K000379) Device Description The AFFINITY® Pediatric Arterial Filter…	Avecor Cardiovascular, Inc.	1995	1
*	K000379	Modofication to Afffinity 38 Micro Arterial Blood Filter with Carmeda Bioactive Surface… Summary page 1 …evices Terumo Capiox Arterial Filter, AF02, Pediatric (K943917) Medtronic Affinity® Arterial Filter (K952532) Medtronic Affinity® Arterial Filter, Carmeda® Coated (K000379) Device Description The AFFINITY® Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to fil…	Medtronic Vascular	2000	—

Also cleared against K943917: 3 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5
K251744	Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial…	Medtronic	2026	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 14, 2013	Class II	Z-1966-2013	Employee error	Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass…
May 9, 2008	Not classified	Z-1921-2008	Nonconforming Material/Component	Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently…

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 descendants of its own.
3 other devices also cite its predicate K943917.

How does its category compare?

All DTM devices

DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DTM

2in 2024

2007high 5 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTM

246in 2009

2007high 246 (2009) · low 60 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTM

1in 2019

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTM

4in 2024

2007high 64 (2014) · low 0 (2009)2025

MAUDE reports naming product code DTM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	60	0	8
2008	1	—	1	2
2009	5	246	0	0
2010	2	—	0	3
2011	1	—	0	8
2012	2	—	0	6
2013	1	—	0	9
2014	0	—	0	64
2015	0	—	0	34
2016	0	—	0	27
2017	0	—	0	15
2018	0	—	0	23
2019	0	—	1	5
2020	0	—	0	1
2021	0	—	0	1
2022	0	—	0	4
2023	1	—	0	0
2024	2	—	0	4
2025	0	—	0	0
2026	1	—	0	—

What is it indicated for?

AFFINITY® Pediatric Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071253 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071253: Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface, Model CB4014.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071253

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026