510(k) Report

510(k) · Cleared

Cleared

Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface, Model 351T

K013084510(k) SpecialCleared Sep 27, 200113-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 Sep 27, 2001 as substantially equivalent to K952532 (Avecor Cardiovascular, Inc., 1995) after a 13-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.

Decided
Sep 27, 2001
Review
13 days
Class
Class II
Product code
DTM
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K952532 (1995). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant clearedReference device: K973760 · Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface · Avecor Cardiovascular, Inc. · 1998 · recalledK952532 · Affinity Arterial Blood Filter · Avecor Cardiovascular, Inc. · 1995 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K952532 · Affinity Arterial Blood Filter · Avecor Cardiovascular, Inc. · 1995 · recalled0+5
  1. Root · 1 generation backK952532 Affinity Arterial Blood FilterAvecor Cardiovascular, Inc. · 1995 · Recalled
  2. This deviceK013084 Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface…Medtronic Perfusion Systems · 2001
  3. Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  4. Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  5. Descendant · 3 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
  6. Descendant · 4 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
  7. Descendant · 5 generations on · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 12025: 12026: 2
2011high 2 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K952532Affinity Arterial Blood FilterAvecor Cardiovascular, Inc.19951
0 (this device)K013084Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface, Model 351TMedtronic Perfusion Systems2001—
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…Medtronic, Inc.2011—
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…Medtronic, Inc.20122
+3K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…Medtronic, Inc.2014—
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.2025—
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201410
202510
202620
FIG. 1 — Lineage of K013084, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251744 Affinity Pixie™ Arterial Filter with Balance™…score 11.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K952532Affinity Arterial Blood Filter
Summary page 1
…DEVICE NAME AFFINITY® 38 i Arterial Blood Filter with Trillium™ Biopassive Surface NAME OF PREDICATED OR LEGALLY MARKETED DEVICE AFFINITY® 38 u Arterial Blood Filter (K952532) i AFFINITY® Hollow Fiber Oxygenator with Trillium ™ Biopassive Surface (K973760) DESCRIPTION OF DEVICE The AFFINITY® 38 u Arte…
Avecor Cardiovascular, Inc.19951
†K973760Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceAvecor Cardiovascular, Inc.19982

Also cleared against K952532: 2 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115

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?

  • Its one ancestor has a recall.
  • Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 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

2007: 32008: 12009: 52010: 22011: 12012: 22013: 12023: 12024: 22026 (partial year): 1
2007high 5 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTM

246in 2009

2007: 60 days median2009: 246 days median
2007high 246 (2009) · low 60 (2007)2026

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

Recalls per year · DTM

1in 2019

2008: 12019: 1
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

2007: 82008: 22010: 32011: 82012: 62013: 92014: 642015: 342016: 272017: 152018: 232019: 52020: 12021: 12022: 42024: 4
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200736008
20081—12
2009524600
20102—03
20111—08
20122—06
20131—09
20140—064
20150—034
20160—027
20170—015
20180—023
20190—15
20200—01
20210—01
20220—04
20231—00
20242—04
20250—00
20261—0—

What is it indicated for?

The AFFINITY® 38 u Arterial Filter with Trillium™ Biopassive Surface 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.

Also cleared against K952532

2 other devices cite the same predicate.

  • K071253Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface, Model CB4014Medtronic Vascular · 20072 recalls
  • K994208Affinity 20 Micron Arterial Blood Filter, Model 353/354Medtronic Perfusion Systems · 2000

More from Medtronic Perfusion Systems

29 FDA decisions under this applicant name. See the company

  • K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion…Medtronic Perfusion Systems · 2024
  • K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems · 2018
  • K123351Affinity AF100 Arterial Filter with Carmeda Bioactive SurfaceMedtronic Perfusion Systems · 2013
  • K101186Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding BagMedtronic Perfusion Systems · 2010
  • K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TDMedtronic Perfusion Systems · 2009

Recent decisions in DTM

The DTM category page

  • K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronic · 2026
  • K242953KIDS Arterial FiltersSorin Group Italia S.R.L. · 2024
  • K242092MICRO Arterial FiltersSorin Group Italia S.R.L. · 2024
  • K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc. · 2023
  • K123351Affinity AF100 Arterial Filter with Carmeda Bioactive SurfaceMedtronic Perfusion Systems · 2013

https://510kreport.com/device/K013084 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013084: Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface, Model 351T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013084

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026