510(k) · Cleared
Recalled · Class II · 2018Tubing Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jun 2, 2017 as substantially equivalent to K151523 (Medtronic, Inc., 2015) after a 30-day review. Its family tree reaches back 5 generations to 1980. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 2, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K800178 (1980). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK800178 Extracorp.'S Intersept Cus. Tubing PK.Extracorporeal Medical Specialities, Inc. · 1980 · Recalled
- 4 generations backK012538 Tubing and Connectors with Trillium Biopassive SurfaceMedtronic Vascular · 2001 · Recalled
- 3 generations backK113845 Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- 2 generations backK122811 Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- 1 generation backK151523 Uncoated Tubing and Connector ComponentsMedtronic, Inc. · 2015
- This deviceK171308 Tubing PackMedtronic, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK171979 Tubing PackMedtronic, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK260043 Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary…Smart Reactors · 2026
- Descendant · 2 generations on · 0 of its ownK213540 Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L · 2022
Most influential descendants
Showing 3 of 3 · See all- K171979Tubing PackMedtronic, Inc. · 2017 · cites it directly2descendants
- K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors · 2026 · 2 generations on0descendants
- K213540Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K800178 | Extracorp.'S Intersept Cus. Tubing PK. | Extracorporeal Medical Specialities, Inc. | 1980 | 10 |
| −4 | K012538 | Tubing and Connectors with Trillium Biopassive Surface | Medtronic Vascular | 2001 | 5 |
| −3 | K113845 | Tubing, Conmnectors, and Accessories Wit Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| −2 | K122811 | Connector Components with Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| −1 | K151523 | Uncoated Tubing and Connector Components | Medtronic, Inc. | 2015 | — |
| 0 (this device) | K171308 | Tubing Pack | Medtronic, Inc. | 2017 | — |
| +1 | K171979 | Tubing Pack | Medtronic, Inc. | 2017 | 25 |
| +2 | K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set… | Smart Reactors | 2026 | — |
| +2 | K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | Qura S.R.L | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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.
Planning a device in DWF? 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? (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 |
|---|---|---|---|
| * | K151523 | Uncoated Tubing and Connector ComponentsSummary page 5…Kxxxxxx 1-46 Predicate Device: K151523 Uncoated Tubing and Connector Components Device Description Medtronic Tubing Packs are used in cardiopulmonary bypass for connec… | 2015 |
| † | K891687 | Extracorporeal Circuit with Bio-Active Surface | 1989 |
| † | K012538 | Tubing and Connectors with Trillium Biopassive Surface | 2001 |
| † | K122811 | Connector Components with Balance Biosurface | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171979 | Tubing Pack | 2017 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2018 | Class II | Z-0535-2018 | Component change control | Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K171979 (Medtronic, Inc., 2017) has gone furthest, with 2 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. 2017, this device’s year, is highlighted.
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 | — |
What is it indicated for?
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171308: Tubing Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171308
Report an extraction error
Are you the manufacturer?
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