510(k) · Cleared
ClearedPump Tubing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DWE Tubing, Pump, Cardiopulmonary Bypass
Cleared on Jan 22, 2002 after an 85-day review. The FDA summary names its predicate without a number. 3 of the 15 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.
- Decided
- Jan 22, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- DWE
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- This deviceK013578 Pump TubingTerumo Cardiovascular Systems Corp. · 2002
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K013578 | Pump Tubing | Terumo Cardiovascular Systems Corp. | 2002 | — |
| +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.
Top candidate predicates for a new DWE device
- #1 K233702 SMARxT Tubing and Connectorsscore 7.8 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | — | Pexco brand PVC tubing Named without a submission number |
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?
- Of its descendants, K053025 (Maquet Cardiopulmonary, AG, 2005) has gone furthest, with 12 descendants of its own.
How does its category compare?
All DWE devicesDWE Tubing, Pump, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DWE
Too few DWE 510(k)s in any year since 2007 to give a median.
Recalls per year · DWE
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWE
80in 2025
MAUDE reports naming product code DWE, 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 | 0 | — | 2 | 10 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 1 | — | 1 | 17 |
| 2010 | 0 | — | 2 | 20 |
| 2011 | 0 | — | 2 | 9 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 1 | — | 1 | 129 |
| 2015 | 1 | — | 0 | 133 |
| 2016 | 0 | — | 0 | 151 |
| 2017 | 0 | — | 2 | 131 |
| 2018 | 0 | — | 0 | 134 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 45 |
| 2021 | 0 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 123 |
| 2023 | 0 | — | 0 | 286 |
| 2024 | 1 | — | 0 | 221 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is also intended to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit.
The tubing is intended for use in procedures lasting up to 6-hours in duration.
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/K013578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013578: Pump Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013578
Report an extraction error
Are you the manufacturer?
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