510(k) · Cleared
ClearedAffinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Nov 20, 2017 as substantially equivalent to K100645 (Medtronic, Inc., 2012) and 1 other predicate after a 54-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Nov 20, 2017
- Review
- 54 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K936003 (1994). 9 ancestors in all, the oldest K831528 (1983). No later device cites it as a predicate yet.
- Root · 4 generations backK936003 Affinity CVRAvecor Cardiovascular, Inc. · 1994 · Recalled
- 3 generations backK021287 Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TTMedtronic Perfusion Systems · 2002 · Recalled
- 2 generations backK100645 Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or…Medtronic, Inc. · 2012
- 1 generation backK141233 Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface…Medtronic, Inc. · 2014
- This deviceK172984 Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie…Medtronic, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936003 | Affinity CVR | Avecor Cardiovascular, Inc. | 1994 | 3 |
| −3 | K021287 | Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT | Medtronic Perfusion Systems | 2002 | 1 |
| −2 | K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance… | Medtronic, Inc. | 2012 | — |
| −1 | K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance… | Medtronic, Inc. | 2014 | — |
| 0 (this device) | 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 |
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 DTZ? 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 DTZ device
- #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 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 |
|---|---|---|---|
| * | K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceSummary page 8…DTZ Predicate Device: Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211) – K100645 Affinity Pixie™ Oxygenator and C… | 2012 |
| * | K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceSummary page 8…my/Venous Reservoir with Balance™ Biosurface (Model BBP241) – K100645 and K141233 Affinity Pixie™ Oxygenator with Cortiva™… | 2014 |
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 23 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K100645.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DTZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTZ
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTZ
1in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DTZ
976in 2025
MAUDE reports naming product code DTZ, 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 | 4 | 55 | 7 | 134 |
| 2008 | 3 | 88 | 5 | 105 |
| 2009 | 9 | 210 | 0 | 52 |
| 2010 | 2 | — | 1 | 119 |
| 2011 | 4 | 160 | 13 | 190 |
| 2012 | 9 | 90 | 14 | 215 |
| 2013 | 9 | 28 | 0 | 346 |
| 2014 | 5 | 28 | 2 | 764 |
| 2015 | 9 | 134 | 0 | 658 |
| 2016 | 3 | 62 | 1 | 443 |
| 2017 | 2 | — | 0 | 388 |
| 2018 | 3 | 72 | 2 (2) | 320 |
| 2019 | 5 | 90 | 1 | 489 |
| 2020 | 5 | 93 | 3 | 442 |
| 2021 | 5 | 336 | 1 (1) | 595 |
| 2022 | 2 | — | 6 | 559 |
| 2023 | 5 | 145 | 0 | 738 |
| 2024 | 3 | 124 | 0 | 535 |
| 2025 | 2 | — | 1 | 976 |
| 2026 | 3 | 137 | 0 | — |
What is it indicated for?
The Affinity Pixie hollow fiber oxygenator with Balance biosurface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 Lmin. 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 CPB procedures up to…
Read the full statement (405 words)
The Affinity Pixie hollow fiber oxygenator with Balance biosurface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 Lmin.
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 CPB procedures up to 6 hours in duration.
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 (CPB) procedures requiring a blood flow rate up to 2.0 Lmin.
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 CPB 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 (VA VD) procedures.
The Affinity Pixie hollow fiber oxygenator with Cortiva bioactive surface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 Lmin.
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 CPB procedures up to 6 hours in duration.
The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Cortiva bioactive surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 Lmin.
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 CPB 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172984: Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172984
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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