510(k) · Cleared
ClearedQuantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qura S.R.L · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on May 20, 2022 as substantially equivalent to K171979 (Medtronic, Inc., 2017) after a 193-day review. Its family tree reaches back 7 generations to 1980.
- Decided
- May 20, 2022
- Review
- 193 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K800178 (1980). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK800178 Extracorp.'S Intersept Cus. Tubing PK.Extracorporeal Medical Specialities, Inc. · 1980 · Recalled
- 6 generations backK012538 Tubing and Connectors with Trillium Biopassive SurfaceMedtronic Vascular · 2001 · Recalled
- 5 generations backK113845 Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- 4 generations backK122811 Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- 3 generations backK151523 Uncoated Tubing and Connector ComponentsMedtronic, Inc. · 2015
- 2 generations backK171308 Tubing PackMedtronic, Inc. · 2017 · Recalled
- 1 generation backK171979 Tubing PackMedtronic, Inc. · 2017 · Recalled
- This deviceK213540 Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K800178 | Extracorp.'S Intersept Cus. Tubing PK. | Extracorporeal Medical Specialities, Inc. | 1980 | 10 |
| −6 | K012538 | Tubing and Connectors with Trillium Biopassive Surface | Medtronic Vascular | 2001 | 5 |
| −5 | K113845 | Tubing, Conmnectors, and Accessories Wit Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| −4 | K122811 | Connector Components with Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| −3 | K151523 | Uncoated Tubing and Connector Components | Medtronic, Inc. | 2015 | — |
| −2 | K171308 | Tubing Pack | Medtronic, Inc. | 2017 | 1 |
| −1 | K171979 | Tubing Pack | Medtronic, Inc. | 2017 | 25 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K171979 | Tubing PackSummary page 5…Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: II Product Code: DWF 510(k) Number K171979 Page 1… | 2017 |
| † | K981613 | Cobe Smarxt Tubing and Connectors | 1998 |
| † | K162774 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 7 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K171979.
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. 2022, 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?
Quantum SuperPAC Tubing Set is a set of tubing intended for use during cardiopulmonary bypass for a duration up to 6 hours.
Quantum SuperPAC Cardioplegia Set is a tubing set used for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213540 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213540: Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213540
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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