510(k) · Cleared
ClearedQuantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS
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 Aug 18, 2022 as substantially equivalent to K203067 (Qura S.R.L, 2021) after a 100-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Aug 18, 2022
- Review
- 100 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003288 (2001). 10 ancestors in all, the oldest K884129 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK003288 Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
- 4 generations backK081820 Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR…Avalon Laboratories, LLC · 2008
- 3 generations backK140999 Tandemheart Veno-Venous CannulaCardiacassist, Inc. · 2014
- 2 generations backK160257 PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. · 2016 · Recalled
- 1 generation backK203067 Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual…Qura S.R.L · 2021
- This deviceK221353 Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual…Qura S.R.L · 2022
- Descendant · cites it directly · 0 of its ownK241248 Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)Spectrum Medical S.R.L. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)Spectrum Medical S.R.L. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003288 | Origen Dual Lumen Catheter | Origen Biomedical, Inc. | 2001 | — |
| −4 | K081820 | Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR… | Avalon Laboratories, LLC | 2008 | — |
| −3 | K140999 | Tandemheart Veno-Venous Cannula | Cardiacassist, Inc. | 2014 | — |
| −2 | K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set | Cardiacassist, Inc. | 2016 | 1 |
| −1 | K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen… | Qura S.R.L | 2021 | — |
| 0 (this device) | K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula… | Qura S.R.L | 2022 | — |
| +1 | K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | Spectrum Medical S.R.L. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F…Summary page 13…Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) 510(k) Number: K203067 IV. DEVICE DESCRIPTION All medical devices pertaining to Quantum Perfusion Dual Lumen Cannula product family are single… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | 2024 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K241248 (Spectrum Medical S.R.L., 2024) 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. 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?
The Quantum Perfusion Dual Lumen Cannula 24F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours. The Quantum Perfusion Dual Lumen Cannula 24F-V 1 is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures…
Read the full statement (353 words)
The Quantum Perfusion Dual Lumen Cannula 24F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
The Quantum Perfusion Dual Lumen Cannula 24F-V 1 is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
The Quantum Perfusion Dual Lumen Cannula 27F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
The Quantum Perfusion Dual Lumen Cannula 27F-V1 is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
The Quantum Perfusion Dual Lumen Cannula 27F-VS is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
The Quantum Perfusion Dual Lumen Cannula 29F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
The Quantum Perfusion Dual Lumen Cannula 29F-V 1 is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
The Quantum Perfusion Dual Lumen Cannula 31F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
The Quantum Perfusion Dual Lumen Cannula 31F-VS is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
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/K221353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221353: Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221353
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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