510(k) · Cleared
ClearedAffinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance Biosuface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Jun 12, 2014 as substantially equivalent to K100645 (Medtronic, Inc., 2012) after a 30-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Jun 12, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K936003 (1994). 8 ancestors in all, the oldest K831528 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK936003 Affinity CVRAvecor Cardiovascular, Inc. · 1994 · Recalled
- 2 generations backK021287 Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TTMedtronic Perfusion Systems · 2002 · Recalled
- 1 generation backK100645 Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or…Medtronic, Inc. · 2012
- This deviceK141233 Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface…Medtronic, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK172984 Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie…Medtronic, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with…Medtronic, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936003 | Affinity CVR | Avecor Cardiovascular, Inc. | 1994 | 3 |
| −2 | K021287 | Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT | Medtronic Perfusion Systems | 2002 | 1 |
| −1 | K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance… | Medtronic, Inc. | 2012 | — |
| 0 (this device) | K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance… | Medtronic, Inc. | 2014 | — |
| +1 | K172984 | Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator… | Medtronic, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 DTN? 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 DTN device
- #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceSummary page 1…I Predicate Devices Medtronic Affinity Pixie& Cardiotomy Venous Reservoir with Carmeda® ioActive Surface or with Balance® Biosurface (K100645) Device Description The Medtronic Affinity Pixie Cardiotomy Venous Reservoir (CVR) is a sin le use devic… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172984 | Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with… | 2017 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K172984 (Medtronic, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K100645.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DTN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTN
38in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTN
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTN
8in 2025
MAUDE reports naming product code DTN, 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 | 2 | — | 1 | 10 |
| 2008 | 1 | — | 1 | 8 |
| 2009 | 7 | 211 | 1 | 10 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 2 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 4 | 79 | 0 | 47 |
| 2014 | 3 | 38 | 0 | 52 |
| 2015 | 2 | — | 0 | 27 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 2 | — | 1 | 3 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Carmeda Bicactive Surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min. The Affinity Pixie Hollow Fiber Oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood…
Read the full statement (251 words)
The Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Carmeda Bicactive Surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie Hollow Fiber Oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity Pixie Cardiotomy/Venous Reservoir is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
The Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie Hallow Fiber Oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity Pixie Cardiotomy/Venous Reservoir is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141233: Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance Biosuface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141233
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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