510(k) · Cleared
Recalled · 2005Closed Chest Support Circuit W/Bio-Active Surface
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 Feb 28, 1990 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 50 devices in its family, counting itself, have a Class I recall. 49 later devices descend from it. It has been recalled once.
- Decided
- Feb 28, 1990
- Review
- 77 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 0
49 later devices descend from it, 1 citing it directly. 4 of the 50 devices in this family, counting this one, have a Class I recall.
- This deviceK896978 Closed Chest Support Circuit W/Bio-Active SurfaceMedtronic Vascular · 1990
- Descendant · cites it directly · 48 of its ownK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- Descendant · 2 generations on · 21 of its ownK020271 Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Recalled (Class I)
- Descendant · 2 generations on · 13 of its ownK991783 AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000
- Descendant · 3 generations on · 11 of its ownK053630 Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006
- Descendant · 3 generations on · 10 of its ownK081221 Levitronix Centrimag Primary Console, Thoratec Centrimag Primary…Levitronix, LLC · 2008
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 49 · See all- K973011BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998 · cites it directly48descendants
- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · 2 generations on21descendants
- K991783AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000 · 2 generations on13descendants
- K053630Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006 · 3 generations on11descendants
- K081221Levitronix Centrimag Primary Console, Thoratec Centrimag Primary ConsoleLevitronix, LLC · 2008 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896978 | Closed Chest Support Circuit W/Bio-Active Surface | Medtronic Vascular | 1990 | — |
| +1 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| +2 | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 | Levitronix, LLC | 2003 | Class I |
| +2 | K991783 | AB-180 XC System, Model AB-180XC | Cardiacassist, Inc. | 2000 | — |
| +3 | K053630 | Levitronix Centrimag Primary Console | Levitronix, LLC | 2006 | — |
| +3 | K081221 | Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console | Levitronix, LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 1 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 1 |
| 2019 | 2 | 1 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (49)
See all 491 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973011 | BPX80 Bio-Pump (BPX80) | 1998 | 48 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2005 | Not classified | Z-0808-05 | Other | Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly & had been… |
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.
- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · 2 generations on · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K973011 (Medtronic Bio-Medicus, Inc., 1998) has gone furthest, with 48 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 | — |
https://510kreport.com/device/K896978 · printed Nov 4, 2026
Cite this page
510(k) Report. “K896978: Closed Chest Support Circuit W/Bio-Active Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896978
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026