510(k) · Cleared
Recalled · 2007Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avecor Cardiovascular, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Feb 18, 1998 after a 139-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 36 devices in its family, counting itself, have a Class I recall. 35 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 18, 1998
- Review
- 139 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 2
- Predicates
- 0
35 later devices descend from it, 11 citing it directly. 2 of the 36 devices in this family, counting this one, have a Class I recall.
- This deviceK973760 Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceAvecor Cardiovascular, Inc. · 1998
- Descendant · cites it directly · 8 of its ownK011864 Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-BMedtronic Vascular · 2001
- Descendant · cites it directly · 7 of its ownK060509 Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with…Tyco Healthcare Group · 2006 · Recalled
- Descendant · cites it directly · 7 of its ownK033468 Affinity 20U Arterial Filter with Trillium BiosurfaceMedtronic Perfusion Systems · 2003
- Descendant · cites it directly · 7 of its ownK012743 Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50TMedtronic Perfusion Systems · 2001
- Descendant · 2 generations on · 6 of its ownK062671 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and…Kendall · 2006 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 35 · See all- K011864Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-BMedtronic Vascular · 2001 · cites it directly8descendants
- K060509Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin CoatingTyco Healthcare Group · 2006 · cites it directly7descendants
- K033468Affinity 20U Arterial Filter with Trillium BiosurfaceMedtronic Perfusion Systems · 2003 · cites it directly7descendants
- K012743Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50TMedtronic Perfusion Systems · 2001 · cites it directly7descendants
- K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…Kendall · 2006 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973760 | Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface | Avecor Cardiovascular, Inc. | 1998 | — |
| +1 | K011864 | Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-B | Medtronic Vascular | 2001 | — |
| +1 | K060509 | Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating | Tyco Healthcare Group | 2006 | 4 |
| +1 | K033468 | Affinity 20U Arterial Filter with Trillium Biosurface | Medtronic Perfusion Systems | 2003 | — |
| +1 | K012743 | Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T | Medtronic Perfusion Systems | 2001 | — |
| +2 | K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver… | Kendall | 2006 | 24 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 1 |
| 2012 | 5 | 0 |
| 2013 | 1 | 1 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (35)
See all 3511 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011864 | Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-B | 2001 | 8 |
| K060509 | Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating | 2006 | 7 |
| K033468 | Affinity 20U Arterial Filter with Trillium Biosurface | 2003 | 7 |
| K012743 | Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T | 2001 | 7 |
| K050109 | Trillium Biopump Plus, Model BPX80T | 2005 | 6 |
| K111972 | Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity… | 2011 | 5 |
| K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface | 2012 | 4 |
| K143073 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT… | 2015 | 2 |
| K122827 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface Model… | 2012 | 2 |
| K111384 | Lifebridge | 2011 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2007 | Not classified | Z-0476-2008 | Nonconforming Material/Component | Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin |
| Mar 25, 2004 | Not classified | Z-0815-04 | Other | An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi…Covidien · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K011864 (Medtronic Vascular, 2001) has gone furthest, with 8 descendants of its own.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
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™ Hollow Fiber Membrane Oxygenator Systems are 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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973760 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973760: Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973760
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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