510(k) · Cleared
Recalled · Class II · 2018Extracorporeal Circuit with Bio-Active Surface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Blood Systems, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on May 31, 1989 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 74 devices in its family, counting itself, have a Class I recall. 73 later devices descend from it. It has been recalled 10 times.
- Decided
- May 31, 1989
- Review
- 70 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 10
- Predicates
- 0
73 later devices descend from it, 8 citing it directly. 4 of the 74 devices in this family, counting this one, have a Class I recall.
- This deviceK891687 Extracorporeal Circuit with Bio-Active SurfaceMedtronic Blood Systems, Inc. · 1989
- 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 · cites it directly · 15 of its ownK031827 Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems · 2003
- Descendant · cites it directly · 13 of its ownK031700 Medtronic Resting Heart System, Model AAR1000 and 711Medtronic Perfusion Systems · 2003 · Recalled
- Descendant · 2 generations on · 13 of its ownK991783 AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 73 · 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
- K031827Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems · 2003 · cites it directly15descendants
- K031700Medtronic Resting Heart System, Model AAR1000 and 711Medtronic Perfusion Systems · 2003 · cites it directly13descendants
- K991783AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891687 | Extracorporeal Circuit with Bio-Active Surface | Medtronic Blood Systems, Inc. | 1989 | — |
| +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 |
| +1 | K031827 | Ultraflex Venous Cannula, Model 970XX and CB970XX | Medtronic Perfusion Systems | 2003 | — |
| +1 | K031700 | Medtronic Resting Heart System, Model AAR1000 and 711 | Medtronic Perfusion Systems | 2003 | 1 |
| +2 | K991783 | AB-180 XC System, Model AB-180XC | Cardiacassist, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 7 | 1 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 1 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 1 |
| 2015 | 2 | 0 |
| 2019 | 2 | 1 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (73)
See all 738 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973011 | BPX80 Bio-Pump (BPX80) | 1998 | 48 |
| K031827 | Ultraflex Venous Cannula, Model 970XX and CB970XX | 2003 | 15 |
| K031700 | Medtronic Resting Heart System, Model AAR1000 and 711 | 2003 | 13 |
| K033416 | Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial… | 2003 | 11 |
| K031037 | Eopa Elongated One-Piece Arterial Cannula and Guidewire | 2003 | 11 |
| K031776 | MC2X Multi-Stage Venous Cannula | 2003 | 7 |
| K111972 | Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity… | 2011 | 5 |
| K973475 | Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr… | 1997 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2018 | Class II | Z-2495-2020 | Nonconforming Material/Component | Affected products failed a sterilization test. |
| Feb 4, 2016 | Class III | Z-1023-2016 | Component design/selection | Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular… |
| Aug 18, 2015 | Class II | Z-2736-2015 | Nonconforming Material/Component | Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic… |
| Jul 17, 2013 | Class II | Z-2105-2013 | Process control | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic. |
| Nov 19, 2012 | Class II | Z-0618-2013 | Package design/selection | Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility. |
| Dec 14, 2011 | Not classified | Z-0813-2012 | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated… |
| May 9, 2008 | Not classified | Z-1920-2008 | Nonconforming Material/Component | Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently… |
| Aug 1, 2007 | Not classified | Z-1227-2007 | Other | Medtronic Custom Tubing Packs might have open header bag seals. |
| Jan 2, 2007 | Not classified | Z-0583-2007 | Other | One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow. |
| Sep 15, 2004 | Not classified | Z-1489-04 | Other | Spiral tip from DLP VAD cannula may be loose and potentially detach during use. |
The 5 latest of 10 recalls; the web page lists all.
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/K891687 · printed Nov 4, 2026
Cite this page
510(k) Report. “K891687: Extracorporeal Circuit with 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/K891687
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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