510(k) · Cleared
ClearedCobe Oxygenator Products
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cobe Cardiovascular, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Jan 27, 1998 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 27, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
COBE® HARD SHELL VENQUS RESERVOIRS, UNFILTERED AND FILTERED are intended for storage (and filtration, if filtered) of blood during surgical procedures on adults requiring extracorporeal circulation for periods up to six hours. COBE® VENQUS RESERVOIR BAGS are intended for use as a blood reservoir during extracorporeal blood circulation. COBE® FLAT SHEET MEMBRANE OXYGENATORS are intended to be used in adult surgical procedures requiring extracorporeal gas…
Read the full statement (133 words)
COBE® HARD SHELL VENQUS RESERVOIRS, UNFILTERED AND FILTERED are intended for storage (and filtration, if filtered) of blood during surgical procedures on adults requiring extracorporeal circulation for periods up to six hours.
COBE® VENQUS RESERVOIR BAGS are intended for use as a blood reservoir during extracorporeal blood circulation.
COBE® FLAT SHEET MEMBRANE OXYGENATORS are intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours (one model is a variable prime oxygenator intended to be used during cardiac surgical procedures on neonates, infants, pediatrics, and small adults requiring cardiopulmonary bypass).
COBE® HOLLOW FIBER MEMBRANE OXYGENATORS are intended to be used in adult surgical procedures requiring extracorporeal gas exchange suppport and blood temperature control for periods of up to six hours.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974085: Cobe Oxygenator Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974085
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026