510(k) · Cleared
ClearedAffinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface Model BB811
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 Dec 14, 2012 as substantially equivalent to K973760 (Avecor Cardiovascular, Inc., 1998) after a 91-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Dec 14, 2012
- Review
- 91 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973760 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK973760 Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceAvecor Cardiovascular, Inc. · 1998 · Recalled
- This deviceK122827 Affinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK142784 Affinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK172626 Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion…Medtronic, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973760 | Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface | Avecor Cardiovascular, Inc. | 1998 | 2 |
| 0 (this device) | K122827 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance… | Medtronic, Inc. | 2012 | — |
| +1 | K142784 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance… | Medtronic, Inc. | 2014 | 1 |
| +2 | K172626 | Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator… | Medtronic, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K973760 | Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceSummary page 1…ary bypass Oxygenator Classification: Class 11, 21 CFR 870.4350 Product Code: DTZ Name of Predicate Device: Affinity NT Oxygenator 511IT (K973760) Device Description:I The Affinity Fusion Hollow Fiber Oxygenator with Integrated Arterial Filter and Balance Biosurface is a si… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142784 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface… | 2014 | 1 |
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?
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 6 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122827: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface Model BB811.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122827
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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