510(k) · Cleared

Cleared

Affinity 20 Micron Arterial Blood Filter, Model 353/354

K994208510(k) SpecialCleared Jan 13, 200030-day reviewClass II21 CFR 870.4260

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

Medtronic Perfusion Systems · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Cleared on Jan 13, 2000 as substantially equivalent to K952532 (Avecor Cardiovascular, Inc., 1995) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1993. 8 later devices descend from it.

Decided: Jan 13, 2000
Review: 30 days
Class: Class II
Product code: DTM
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K926413 (1993). 2 ancestors in all. 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK926413 Medtronic Arterial FilterMedtronic Vascular · 1993
This deviceK994208 Affinity 20 Micron Arterial Blood Filter, Model 353/354Medtronic Perfusion Systems · 2000
Descendant · cites it directly · 7 of its ownK033468 Affinity 20U Arterial Filter with Trillium BiosurfaceMedtronic Perfusion Systems · 2003
Descendant · 2 generations on · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
Descendant · 3 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
Descendant · 4 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
Descendant · 5 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2003high 2 (2012) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all

K033468Affinity 20U Arterial Filter with Trillium BiosurfaceMedtronic Perfusion Systems · 2003 · cites it directly7descendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · 2 generations on5descendants
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 3 generations on4descendants
K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 4 generations on2descendants
K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 5 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926413	Medtronic Arterial Filter	Medtronic Vascular	1993	—
0 (this device)	K994208	Affinity 20 Micron Arterial Blood Filter, Model 353/354	Medtronic Perfusion Systems	2000	—
+1	K033468	Affinity 20U Arterial Filter with Trillium Biosurface	Medtronic Perfusion Systems	2003	—
+2	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—
+3	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2
+4	K140165	MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…	Medtronic, Inc.	2014	—
+5	K251258	MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula	Medtronic, Inc.	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2011	1	0
2012	2	0
2014	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K994208, 1993–2026Source: 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? (2)

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
*	K952532	Affinity Arterial Blood Filter Summary page 1 …r of Regulatory/Clinical Affairs DEVICE NAME AFFINITY® 20u Arterial Blood Filter NAME OF PREDICATED OR LEGALLY MARKETED DEVICE AFFINITY® 38 pu Arterial Blood Filter (K952532) INTERSEPT® 20 p Arterial Blood Filter (K926413) DESCRIPTION OF DEVICE The 20 p arterial blood filter is a single use device de…	Avecor Cardiovascular, Inc.	1995	1
*	K926413	Medtronic Arterial Filter Summary page 1 …FFINITY® 20u Arterial Blood Filter NAME OF PREDICATED OR LEGALLY MARKETED DEVICE AFFINITY® 38 pu Arterial Blood Filter (K952532) INTERSEPT® 20 p Arterial Blood Filter (K926413) DESCRIPTION OF DEVICE The 20 p arterial blood filter is a single use device designed to filter microemboli from the blood in t…	Medtronic Vascular	1993	—

Also cleared against K952532: 2 other devices →

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033468	Affinity 20U Arterial Filter with Trillium Biosurface	Medtronic Perfusion Systems	2003	7

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K033468 (Medtronic Perfusion Systems, 2003) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K952532.

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.

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?

The Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the

removal of particulate and gaseous microemboli.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K994208 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994208: Affinity 20 Micron Arterial Blood Filter, Model 353/354.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994208

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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