510(k) · Cleared
Recalled · Class II · 2016Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda 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 Oct 24, 2014 as substantially equivalent to K122827 (Medtronic, Inc., 2012) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 24, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973760 (1998). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK973760 Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceAvecor Cardiovascular, Inc. · 1998 · Recalled
- 1 generation backK122827 Affinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic, Inc. · 2012
- This deviceK142784 Affinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK172626 Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion…Medtronic, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K172626Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion 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 |
|---|---|---|---|---|---|
| −2 | K973760 | Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface | Avecor Cardiovascular, Inc. | 1998 | 2 |
| −1 | K122827 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance… | Medtronic, Inc. | 2012 | — |
| 0 (this device) | K142784 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance… | Medtronic, Inc. | 2014 | — |
| +1 | K172626 | Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator… | Medtronic, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2013 | 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 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 |
|---|---|---|---|
| * | K122827 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface Model…Summary page 5…DTZ Name of Predicate Device: Affinity Fusion® Oxygenator with Integrated Arterial Filter and with Balance™ Biosurface, Model BB811 (K122827) Affinity Fusion® Oxygenator with Integrated Arterial Filter and w… | 2012 |
| * | K123314 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive SurfaceSummary page 5…finity Fusion® Oxygenator with Integrated Arterial Filter and with Carmeda® BioActive Surface, Model CB811 (K123314) Affinity Fusion Oxygenators KXXXXXX Medtronic Confidential… | 2013 |
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 |
|---|---|---|---|
| K172626 | Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with… | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 16, 2016 | Class II | Z-0826-2017 | Process control | Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 14.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K172626 (Medtronic, Inc., 2017) has gone furthest, with 0 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. 2014, 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 Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface 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 six hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than…
Read the full statement (168 words)
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface 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 six hours in duration.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active Surface 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 six hours in duration.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active Surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.
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/K142784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142784: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda 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/K142784
Report an extraction error
Are you the manufacturer?
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