510(k) · Cleared
ClearedTubing Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cobe Laboratories, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Oct 4, 1977 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 16 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it.
- Decided
- Oct 4, 1977
- Review
- 28 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly. 3 of the 16 devices in this family, counting this one, have a Class I recall.
- This deviceK771692 Tubing SetsCobe Laboratories, Inc. · 1977
- Descendant · cites it directly · 12 of its ownK053025 Jostra HLM Tubing SetMaquet Cardiopulmonary, AG · 2005 · Recalled
- Descendant · 2 generations on · 8 of its ownK080592 HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · Recalled
- Descendant · 3 generations on · 3 of its ownK090533 HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG · 2009
- Descendant · 3 generations on · 2 of its ownK200109 OXY-1 SystemAbiomed, Inc. · 2020 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K053025Jostra HLM Tubing SetMaquet Cardiopulmonary, AG · 2005 · cites it directly12descendants
- K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · 2 generations on8descendants
- K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG · 2009 · 3 generations on3descendants
- K200109OXY-1 SystemAbiomed, Inc. · 2020 · 3 generations on2descendants
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K771692 | Tubing Sets | Cobe Laboratories, Inc. | 1977 | — |
| +1 | K053025 | Jostra HLM Tubing Set | Maquet Cardiopulmonary, AG | 2005 | 2 |
| +2 | K080592 | HLM Tubing Set with Bioline Coating | Maquet Cardiopulmonary, AG | 2008 | 221 |
| +3 | K090533 | HLM Tubing Set with Softline Coating | Maquet Cardiopulmonary, AG | 2009 | — |
| +3 | K200109 | OXY-1 System | Abiomed, Inc. | 2020 | Class I |
| +3 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 2 | 1 |
| 2020 | 2 | 1 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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.
3 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 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? (15)
See all 153 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
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.
- K200109OXY-1 SystemAbiomed, Inc. · 2020 · 3 generations on · ◆ in the 2020 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
What does this lineage say?
- Of its descendants, K053025 (Maquet Cardiopulmonary, AG, 2005) has gone furthest, with 12 descendants of its own.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, 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 | 2 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
https://510kreport.com/device/K771692 · printed Nov 5, 2026
Cite this page
510(k) Report. “K771692: Tubing Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K771692
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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