510(k) · Cleared
ClearedAffinity Pixie Arterial Filter with Balance Biosurface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Dec 16, 2010 after a 286-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Dec 16, 2010
- Review
- 286 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK100646 Affinity Pixie Arterial Filter with Balance BiosurfaceMedtronic, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK113845 Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK122811 Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 4 of its ownK151523 Uncoated Tubing and Connector ComponentsMedtronic, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK171308 Tubing PackMedtronic, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 2 of its ownK171979 Tubing PackMedtronic, Inc. · 2017 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K113845Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · cites it directly7descendants
- K122811Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · 2 generations on5descendants
- K151523Uncoated Tubing and Connector ComponentsMedtronic, Inc. · 2015 · 2 generations on4descendants
- K171308Tubing PackMedtronic, Inc. · 2017 · 3 generations on3descendants
- K171979Tubing PackMedtronic, Inc. · 2017 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100646 | Affinity Pixie Arterial Filter with Balance Biosurface | Medtronic, Inc. | 2010 | — |
| +1 | K113845 | Tubing, Conmnectors, and Accessories Wit Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| +2 | K122811 | Connector Components with Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| +2 | K151523 | Uncoated Tubing and Connector Components | Medtronic, Inc. | 2015 | — |
| +3 | K171308 | Tubing Pack | Medtronic, Inc. | 2017 | 1 |
| +4 | K171979 | Tubing Pack | Medtronic, Inc. | 2017 | 25 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
| 2026 | 2 | 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? (11)
See all 113 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?
- Of its descendants, K113845 (Medtronic, Inc., 2012) has gone furthest, with 7 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. 2010, 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 | — |
https://510kreport.com/device/K100646 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100646: Affinity Pixie Arterial Filter with Balance Biosurface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100646
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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