510(k) · Cleared
ClearedAffinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance Biocompatible Surface (Model 511B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Sep 15, 1999 as substantially equivalent to K932252 (Avecor Cardiovascular, Inc., 1993) and 1 other predicate after a 16-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Sep 15, 1999
- Review
- 16 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932252 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- This deviceK992910 Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with…Medtronic Vascular · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| 0 (this device) | K992910 | Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance… | Medtronic Vascular | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K932252 | Affinity Hollow Fiber OxygenatorSummary page 1…ollow Fiber Oxygenator with Plasma Resistant Fiber with Balance™ Biocompatible Surface NAME OF PREDICATE OR LEGALLY MARKETED DEVICE e AFFINITY®Hollow Fiber Oxygenator (K932252) e MAXIMA FORTE® Hollow Fiber Oxygenator with Balance™ Biocompatible Surface with Plasma Resistant Fiber (K984271) DESCRIPTION O… | 1993 |
| * | K984271 | Modification of Maxima Forte' Hollow Fiber Oxygenator with Balance Biocompatible Surface…Summary page 1…LY MARKETED DEVICE e AFFINITY®Hollow Fiber Oxygenator (K932252) e MAXIMA FORTE® Hollow Fiber Oxygenator with Balance™ Biocompatible Surface with Plasma Resistant Fiber (K984271) DESCRIPTION OF DEVICE The Medtronic AFFINITY®NT Oxygenator with Balance™ Biocompatible Surface is a single-use, disposable, st… | 1999 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K932252.
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 Medtronic AFFINITY® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance™ Biocompatible Surface is intended for use 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 summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992910 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992910: Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance Biocompatible Surface (Model 511B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992910
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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