510(k) · Cleared
Recalled · Class II · 2019Affinity Arterial Blood Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avecor Cardiovascular, Inc. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Oct 6, 1995 after a 127-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it. It has been recalled once.
- Decided
- Oct 6, 1995
- Review
- 127 days
- Class
- Class II
- Product code
- DTM
- Recalls
- 1
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK952532 Affinity Arterial Blood FilterAvecor Cardiovascular, Inc. · 1995
- Descendant · cites it directly · 8 of its ownK994208 Affinity 20 Micron Arterial Blood Filter, Model 353/354Medtronic Perfusion Systems · 2000
- Descendant · cites it directly · 7 of its ownK071253 Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda…Medtronic Vascular · 2007 · Recalled
- Descendant · 2 generations on · 7 of its ownK033468 Affinity 20U Arterial Filter with Trillium BiosurfaceMedtronic Perfusion Systems · 2003
- Descendant · cites it directly · 6 of its ownK013084 Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface…Medtronic Perfusion Systems · 2001
- Descendant · 2 generations on · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K994208Affinity 20 Micron Arterial Blood Filter, Model 353/354Medtronic Perfusion Systems · 2000 · cites it directly8descendants
- K071253Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface…Medtronic Vascular · 2007 · cites it directly7descendants
- K033468Affinity 20U Arterial Filter with Trillium BiosurfaceMedtronic Perfusion Systems · 2003 · 2 generations on7descendants
- K013084Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface, Model 351TMedtronic Perfusion Systems · 2001 · cites it directly6descendants
- K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952532 | Affinity Arterial Blood Filter | Avecor Cardiovascular, Inc. | 1995 | — |
| +1 | K994208 | Affinity 20 Micron Arterial Blood Filter, Model 353/354 | Medtronic Perfusion Systems | 2000 | — |
| +1 | K071253 | Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive… | Medtronic Vascular | 2007 | 2 |
| +2 | K033468 | Affinity 20U Arterial Filter with Trillium Biosurface | Medtronic Perfusion Systems | 2003 | — |
| +1 | K013084 | Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface, Model 351T | Medtronic Perfusion Systems | 2001 | — |
| +2 | K111972 | Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia… | Medtronic, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 123 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2019 | Class II | Z-0693-2020 | Process control | Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K994208 (Medtronic Perfusion Systems, 2000) has gone furthest, with 8 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 | — |
https://510kreport.com/device/K952532 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952532: Affinity Arterial Blood Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952532
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026