510(k) · Cleared
Recalled · Class II · 2021Tubing 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 Oct 27, 2017 as substantially equivalent to K171308 (Medtronic, Inc., 2017) after a 119-day review. Its family tree reaches back 6 generations to 1980. 2 later devices descend from it. It has been recalled 25 times.
- Decided
- Oct 27, 2017
- Review
- 119 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 25
- Predicates
- 1
Its longest line of descent runs back 6 generations to K800178 (1980). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK800178 Extracorp.'S Intersept Cus. Tubing PK.Extracorporeal Medical Specialities, Inc. · 1980 · Recalled
- 5 generations backK012538 Tubing and Connectors with Trillium Biopassive SurfaceMedtronic Vascular · 2001 · Recalled
- 4 generations backK113845 Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- 3 generations backK122811 Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- 2 generations backK151523 Uncoated Tubing and Connector ComponentsMedtronic, Inc. · 2015
- 1 generation backK171308 Tubing PackMedtronic, Inc. · 2017 · Recalled
- This deviceK171979 Tubing PackMedtronic, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK260043 Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary…Smart Reactors · 2026
- Descendant · cites it directly · 0 of its ownK213540 Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K800178 | Extracorp.'S Intersept Cus. Tubing PK. | Extracorporeal Medical Specialities, Inc. | 1980 | 10 |
| −5 | K012538 | Tubing and Connectors with Trillium Biopassive Surface | Medtronic Vascular | 2001 | 5 |
| −4 | K113845 | Tubing, Conmnectors, and Accessories Wit Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| −3 | K122811 | Connector Components with Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| −2 | K151523 | Uncoated Tubing and Connector Components | Medtronic, Inc. | 2015 | — |
| −1 | K171308 | Tubing Pack | Medtronic, Inc. | 2017 | 1 |
| 0 (this device) | K171979 | Tubing Pack | Medtronic, Inc. | 2017 | — |
| +1 | K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set… | Smart Reactors | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K171308 | Tubing PackSummary page 5…cation Panel: Cardiovascular Regulation Number: 21 CFR 870.4210 Product Code: DWF Classification: Class II Predicate Device: K171308 Tubing Pack Device Description Medtronic Tubing Packs are used in cardiopulmonary bypass procedures for connecting the primary d… | 2017 |
| † | K800178 | Extracorp.'S Intersept Cus. Tubing PK. | 1980 |
| † | K883956 | Bio-Medicus Tubing Connectors | 1988 |
| † | K924529 | Signature (TM) Custom Tubing Pack | 1993 |
| † | K891687 | Extracorporeal Circuit with Bio-Active Surface | 1989 |
| † | K012538 | Tubing and Connectors with Trillium Biopassive Surface | 2001 |
| † | K113845 | Tubing, Conmnectors, and Accessories Wit Balance Biosurface | 2012 |
| † | K122811 | Connector Components with Balance Biosurface | 2012 |
| † | K151523 | Uncoated Tubing and Connector Components | 2015 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2021 | Class II | Z-1893-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1872-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1882-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1886-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1890-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1888-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1880-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1881-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1874-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1895-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1873-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1875-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1871-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1879-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1887-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1878-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1876-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1889-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1884-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1883-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1891-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1892-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1894-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1877-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Apr 29, 2021 | Class II | Z-1885-2021 | Nonconforming Material/Component | Specific lots may have been manufactured with insufficient or incomplete welds. |
The 5 latest of 25 recalls; the web page lists all.
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.
- 6 of the 9 ancestors have a recall of any class.
- Of its descendants, K260043 (Smart Reactors, 2026) has gone furthest, with 0 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/K171979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171979: 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/K171979
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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