510(k) · Cleared
ClearedAffinity 20U Arterial Filter with Trillium Biosurface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Perfusion Systems · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Nov 14, 2003 as substantially equivalent to K994208 (Medtronic Perfusion Systems, 2000) and 1 other predicate after an 11-day review. Its family tree reaches back 2 generations to 1993. 7 later devices descend from it.
- Decided
- Nov 14, 2003
- Review
- 11 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926413 (1993). 4 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK926413 Medtronic Arterial FilterMedtronic Vascular · 1993
- 1 generation backK994208 Affinity 20 Micron Arterial Blood Filter, Model 353/354Medtronic Perfusion Systems · 2000
- This deviceK033468 Affinity 20U Arterial Filter with Trillium BiosurfaceMedtronic Perfusion Systems · 2003
- 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
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 |
|---|---|---|---|---|---|
| −2 | K926413 | Medtronic Arterial Filter | Medtronic Vascular | 1993 | — |
| −1 | K994208 | Affinity 20 Micron Arterial Blood Filter, Model 353/354 | Medtronic Perfusion Systems | 2000 | — |
| 0 (this device) | K033468 | Affinity 20U Arterial Filter with Trillium Biosurface | Medtronic Perfusion Systems | 2003 | — |
| +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 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K994208 | Affinity 20 Micron Arterial Blood Filter, Model 353/354Summary page 1…Affairs DEVICE NAME AFFINITY@20 p Arterial Blood Filter with Trillium”” Biosurface NAME OF PREDICATED OR LEGALLY MARKETED DEVICE AFFINITY@20 p Arterial Blood Filter (K994208) AFFINITY@Hollow Fiber Oxygenator with Trilliumr” Biosurface (K973760) DESCRIPTION OF DEVICE The AFFINITY@20 p Arterial Blood F… | 2000 |
| * | K973760 | Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceSummary page 1…m”” Biosurface NAME OF PREDICATED OR LEGALLY MARKETED DEVICE AFFINITY@20 p Arterial Blood Filter (K994208) AFFINITY@Hollow Fiber Oxygenator with Trilliumr” Biosurface (K973760) DESCRIPTION OF DEVICE The AFFINITY@20 p Arterial Blood Filter with Trillium”” Biosurface is a single use device designed to fi… | 1998 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DTM devicesDTM 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DTM
246in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTM
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTM
4in 2024
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 AFFINITY@Arterial Filter with TrilliumTMBiosurface 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/K033468 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033468: Affinity 20U Arterial Filter with Trillium Biosurface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033468
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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