510(k) · Cleared
Recalled · Class II · 2015Extracorp.'S Intersept Cus. Tubing PK.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Extracorporeal Medical Specialities, Inc. · DWE Tubing, Pump, Cardiopulmonary Bypass
Cleared on Feb 21, 1980 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 29 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it. It has been recalled 10 times.
- Decided
- Feb 21, 1980
- Review
- 24 days
- Class
- Class II
- Product code
- DWE
- Recalls
- 10
- Predicates
- 0
28 later devices descend from it, 3 citing it directly. 3 of the 29 devices in this family, counting this one, have a Class I recall.
- This deviceK800178 Extracorp.'S Intersept Cus. Tubing PK.Extracorporeal Medical Specialities, Inc. · 1980
- Descendant · cites it directly · 14 of its ownK012538 Tubing and Connectors with Trillium Biopassive SurfaceMedtronic Vascular · 2001 · Recalled
- 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 · cites it directly · 7 of its ownK113845 Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK122811 Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K012538Tubing and Connectors with Trillium Biopassive SurfaceMedtronic Vascular · 2001 · cites it directly14descendants
- K053025Jostra HLM Tubing SetMaquet Cardiopulmonary, AG · 2005 · cites it directly12descendants
- K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · 2 generations on8descendants
- K113845Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · cites it directly7descendants
- K122811Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K800178 | Extracorp.'S Intersept Cus. Tubing PK. | Extracorporeal Medical Specialities, Inc. | 1980 | — |
| +1 | K012538 | Tubing and Connectors with Trillium Biopassive Surface | Medtronic Vascular | 2001 | 5 |
| +1 | K053025 | Jostra HLM Tubing Set | Maquet Cardiopulmonary, AG | 2005 | 2 |
| +2 | K080592 | HLM Tubing Set with Bioline Coating | Maquet Cardiopulmonary, AG | 2008 | 221 |
| +1 | K113845 | Tubing, Conmnectors, and Accessories Wit Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| +2 | K122811 | Connector Components with Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 1 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 1 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 1 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 DWE device
- #1 K233702 SMARxT Tubing and Connectorsscore 7.8 · 1 generation · no Class I recall
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? (28)
See all 283 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 |
|---|---|---|---|---|
| Aug 18, 2015 | Class II | Z-2736-2015 | Nonconforming Material/Component | Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic… |
| Jan 30, 2014 | Class II | Z-1000-2014 | Under Investigation by firm | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. |
| Jul 17, 2013 | Class II | Z-2104-2013 | Process control | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic. |
| Nov 19, 2012 | Class II | Z-0618-2013 | Package design/selection | Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility. |
| Dec 14, 2011 | Not classified | Z-0814-2012 | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated… |
| Feb 25, 2009 | Not classified | Z-1424-2009 | Device Design | Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a… |
| Aug 1, 2007 | Not classified | Z-1227-2007 | Other | Medtronic Custom Tubing Packs might have open header bag seals. |
| Jan 2, 2007 | Not classified | Z-0583-2007 | Other | One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow. |
| Sep 13, 2006 | Not classified | Z-0340-2007 | Other | An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications. |
| Mar 25, 2005 | Not classified | Z-0808-05 | Other | Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly & had been… |
The 5 latest of 10 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, K012538 (Medtronic Vascular, 2001) has gone furthest, with 14 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 | — |
https://510kreport.com/device/K800178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K800178: Extracorp.'S Intersept Cus. Tubing PK..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800178
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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