510(k) · Cleared
Recalled · 2006Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane Oxygenator
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 Nov 16, 2001 as substantially equivalent to K991452 (Cobe Cardiovascular, Inc., 1999) after a 28-day review. Its family tree reaches back 2 generations to 1996. It has been recalled 2 times.
- Decided
- Nov 16, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960074 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK960074 Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous…Terumo Medical Corp. · 1996
- 1 generation backK991452 Cobe Optimin Hollow Fiber Membrane OxygenatorCobe Cardiovascular, Inc. · 1999 · Recalled
- This deviceK013480 Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane OxygenatorCobe Cardiovascular, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960074 | Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir | Terumo Medical Corp. | 1996 | — |
| −1 | K991452 | Cobe Optimin Hollow Fiber Membrane Oxygenator | Cobe Cardiovascular, Inc. | 1999 | 2 |
| 0 (this device) | K013480 | Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane Oxygenator | Cobe Cardiovascular, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (1)
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 |
|---|---|---|---|
| * | K991452 | Cobe Optimin Hollow Fiber Membrane OxygenatorSummary page 1…xchanger CLASSIFICATION NAME: Cardiopulmonary Bypass Oxygenator Cardiopulmonary Bypass Heat Exchanger PREDICATE DEVICE: COBE Optimin Hollow Fiber Membrane Oxygenator, #K991452 DEVICE DESCRIPTION/INDICATIONS FOR USE The COBE SMARXT Optimin is a sterile device with non-pyrogenic fluid pathways, for single… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2006 | Not classified | Z-1424-06 | Other | Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the… |
| Jun 26, 2006 | Not classified | Z-1427-06 | Other | Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K991452.
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 COBE® SMARXT® Optimin™ is indicated for use in surgical
procedures requiring extracorporeal gas exchange support and blood
temperature control. It is intended to be used in procedures requiring a
maximum blood flow rate of 5 liters/min and lasting 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/K013480 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013480: Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane Oxygenator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013480
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026