510(k) · Cleared
Recalled · Class II · 2020Tubing Connectors EC-2XXX Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gish Biomedical, Inc. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Dec 16, 1983 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 22 times.
- Decided
- Dec 16, 1983
- Review
- 81 days
- Class
- Class II
- Product code
- DTL
- Recalls
- 22
- Predicates
- 0
13 later devices descend from it, 2 citing it directly. 3 of the 14 devices in this family, counting this one, have a Class I recall.
- This deviceK833322 Tubing Connectors EC-2XXX SeriesGish Biomedical, Inc. · 1983
- 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 13 descendants. See all descendants
Descendants cleared per year
2005high 3 (2009) · low 0 (2007)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · 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) | K833322 | Tubing Connectors EC-2XXX Series | Gish Biomedical, Inc. | 1983 | — |
| +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 | 1 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (13)
See all 132 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2020 | Class II | Z-2448-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2443-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2449-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2452-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2450-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2454-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2462-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2451-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2458-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2447-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2455-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2456-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2457-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2459-2020 | Packaging process control | XXX |
| Apr 24, 2020 | Class II | Z-2444-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2446-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2461-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2445-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Apr 24, 2020 | Class II | Z-2460-2020 | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a… |
| Nov 18, 2019 | Class III | Z-2642-2020 | Packaging process control | Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use… |
| Sep 14, 2012 | Class II | Z-0157-2013 | Process control | Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury. |
| Sep 14, 2012 | Class II | Z-0158-2013 | Process control | Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury. |
The 5 latest of 22 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.
- 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 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
2007high 8 (2012) · low 0 (2011)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DTL
36in 2012
2007high 115 (2010) · low 36 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTL
1in 2025
2007high 3 (2010) · low 0 (2007)2026
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DTL
110in 2025
2007high 452 (2024) · low 16 (2008)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) | — |
https://510kreport.com/device/K833322 · printed Nov 5, 2026
Cite this page
510(k) Report. “K833322: Tubing Connectors EC-2XXX Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K833322
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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