510(k) · Cleared
ClearedMaxima Forte Hollow Fiber Oxygenator with Plasma Resistant Fiber
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 Dec 16, 1996 as substantially equivalent to K941473 (Medtronic Vascular, 1995) and 1 other predicate after a 164-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Dec 16, 1996
- Review
- 164 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872107 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK872107 William Harvey HF5000 Membrane OxygenatorMinntech Corp. · 1987
- This deviceK962641 Maxima Forte Hollow Fiber Oxygenator with Plasma Resistant FiberMedtronic Vascular · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872107 | William Harvey HF5000 Membrane Oxygenator | Minntech Corp. | 1987 | — |
| 0 (this device) | K962641 | Maxima Forte Hollow Fiber Oxygenator with Plasma Resistant Fiber | Medtronic Vascular | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K941473 | Maxima Plus Hollow Fiber OxygenatorSummary page 1…h Plasma Resistant Fiber (Model: MAX-FTE) NAME OF PREDICATE OR LEGALLY MARKETED DEVICE . MAXIMA PLUS" PRF Hollow Fiber Oxygenator with Improved Plasma Resistant Fiber (K941473) . BARD® WILLIAM HARVEY® HF-5000 Membrane Oxygenator (K872107). DESCRIPTION OF DEVICE The Medtronic MAXIMA FORTE™ Hollow Fiber… | 1995 |
| * | K872107 | William Harvey HF5000 Membrane OxygenatorSummary page 1…LEGALLY MARKETED DEVICE . MAXIMA PLUS" PRF Hollow Fiber Oxygenator with Improved Plasma Resistant Fiber (K941473) . BARD® WILLIAM HARVEY® HF-5000 Membrane Oxygenator (K872107). DESCRIPTION OF DEVICE The Medtronic MAXIMA FORTE™ Hollow Fiber Oxygenator with Plasma Resistant Fiber is a single use, dispos… | 1987 |
| † | K922799 | Capiox SX Hollow Fiber Oxygenator | 1993 |
| † | K932252 | Affinity Hollow Fiber Oxygenator | 1993 |
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.
- 1 other device also cites its predicate K941473.
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?
MAXIMA FORTE™ Hollow Fiber Oxygenator with Plasma Resistant Fiber is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from blood and is designed to operate at blood flow rates between 1 and 7 liters per minute for periods up to six hours.
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/K962641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962641: Maxima Forte Hollow Fiber Oxygenator with Plasma Resistant Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962641
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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