510(k) · Cleared
ClearedAffinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Jan 16, 2026 as substantially equivalent to K100646 (Medtronic, Inc., 2010) and 1 other predicate after a 224-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jan 16, 2026
- Review
- 224 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943917 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK943917 Capiox Arterial FilterTerumo Medical Corp. · 1995
- 1 generation backK071253 Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda…Medtronic Vascular · 2007 · Recalled
- This deviceK251744 Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity®…Medtronic · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943917 | Capiox Arterial Filter | Terumo Medical Corp. | 1995 | — |
| −1 | K071253 | Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive… | Medtronic Vascular | 2007 | 2 |
| 0 (this device) | K251744 | Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric… | Medtronic | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2010 | 1 | 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 K242953 KIDS Arterial Filtersscore 9.4 · 4 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 |
|---|---|---|---|
| * | K100646 | Affinity Pixie Arterial Filter with Balance BiosurfaceSummary page 7…rterial Filter with BB4014 Balance™ Biosurface K100646 M942233A001 Affinity Pixie™ Arterial Filter with (non-sterile BB4014) Balance™ Biosurface, non-ster… | 2010 |
| * | K071253 | Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface…Summary page 7…ediatric Arterial Blood S4014 Filter K071253 M929334A001 Affinity® Pediatric Arterial Blood (non-sterile S4014) Filter, non-sterile K17… | 2007 |
| † | K171979 | Tubing Pack | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 3 companies; a new generation was cleared every 18.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K100646.
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. 2026, this device’s year, is highlighted.
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® Pediatric Arterial Blood Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in
duration for the removal of particulate and gaseous microemboli.
The Affinity Pixie™ 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/K251744 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251744: Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric 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/K251744
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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