510(k) · Cleared
ClearedTerumo Circuit Connectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corporation · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Aug 11, 2004 as substantially equivalent to K895753 (Brevet, Inc., 1989) after a 50-day review. Its family tree reaches back 1 generation to 1989. 3 of the 16 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.
- Decided
- Aug 11, 2004
- Review
- 50 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895753 (1989). 14 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.
- Root · 1 generation backK895753 Brevet Disposable ConnectorsBrevet, Inc. · 1989
- This deviceK041697 Terumo Circuit ConnectorsTerumo Cardiovascular Systems Corporation · 2004
- 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 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · 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 |
|---|---|---|---|---|---|
| −1 | K895753 | Brevet Disposable Connectors | Brevet, Inc. | 1989 | — |
| 0 (this device) | K041697 | Terumo Circuit Connectors | Terumo Cardiovascular Systems Corporation | 2004 | — |
| +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 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 2 | 1 |
| 2020 | 1 | 1 |
| 2022 | 1 | 0 |
| 2023 | 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.
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K895753 | Brevet Disposable ConnectorsSummary page 1…Proposed Device Predicate Device 0007-04439 - U-Tube Connector Brevet Connector (K895753) 0007-02118 - 3/16 Male Slip Connector Brevet Connector (K895753) - P/N 118 0007-03056 - I/ 4" Qui… | 1989 |
What descends from it? (14)
See all 143 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?
- Its one ancestor has no recall.
- Of its descendants, K053025 (Maquet Cardiopulmonary, AG, 2005) has gone furthest, with 12 descendants of its own.
How does its category compare?
All DTL devicesDTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTL
36in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTL
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DTL
110in 2025
MAUDE reports naming product code DTL, 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 | 1 | — | 0 | 37 |
| 2008 | 5 | 85 | 1 | 16 |
| 2009 | 2 | — | 0 | 62 |
| 2010 | 4 | 115 | 3 | 148 |
| 2011 | 0 | — | 1 | 160 |
| 2012 | 8 | 36 | 2 | 53 |
| 2013 | 1 | — | 1 (1) | 67 |
| 2014 | 2 | — | 1 | 80 |
| 2015 | 1 | — | 0 | 89 |
| 2016 | 0 | — | 0 | 67 |
| 2017 | 0 | — | 2 | 106 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 2 | 48 |
| 2023 | 0 | — | 0 | 46 |
| 2024 | 0 | — | 0 | 452 |
| 2025 | 0 | — | 1 | 110 |
| 2026 | 0 | — | 3 (3) | — |
What is it indicated for?
The Terumo Circuit Connectors are intended to be used to interconnect tubing and other devices within a circuit during extra-corporeal bypass procedures. The devices can be used in procedures lasting up to 6 hours in duration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041697 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041697: Terumo Circuit Connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041697
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026