510(k) · Cleared
ClearedTandemheart Veno-Venous Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiacassist, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Aug 6, 2014 as substantially equivalent to K081820 (Avalon Laboratories, LLC, 2008) and 1 other predicate after a 110-day review. Its family tree reaches back 2 generations to 2001. 7 later devices descend from it.
- Decided
- Aug 6, 2014
- Review
- 110 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003288 (2001). 4 ancestors in all, the oldest K924642 (1993). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK003288 Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
- 1 generation backK081820 Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR…Avalon Laboratories, LLC · 2008
- This deviceK140999 Tandemheart Veno-Venous CannulaCardiacassist, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK160257 PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK203067 Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual…Qura S.R.L · 2021
- Descendant · 3 generations on · 1 of its ownK221353 Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual…Qura S.R.L · 2022
- Descendant · 2 generations on · 1 of its ownK181150 ProtekDuo Mini Veno-Venous Cannula SetCardiacassist, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK241248 Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)Spectrum Medical S.R.L. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. · 2016 · cites it directly5descendants
- K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F…Qura S.R.L · 2021 · 2 generations on2descendants
- K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F…Qura S.R.L · 2022 · 3 generations on1descendant
- K181150ProtekDuo Mini Veno-Venous Cannula SetCardiacassist, Inc. · 2018 · 2 generations on1descendant
- K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)Spectrum Medical S.R.L. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003288 | Origen Dual Lumen Catheter | Origen Biomedical, Inc. | 2001 | — |
| −1 | K081820 | Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR… | Avalon Laboratories, LLC | 2008 | — |
| 0 (this device) | K140999 | Tandemheart Veno-Venous Cannula | Cardiacassist, Inc. | 2014 | — |
| +1 | K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set | Cardiacassist, Inc. | 2016 | 1 |
| +2 | K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen… | Qura S.R.L | 2021 | — |
| +3 | K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula… | Qura S.R.L | 2022 | — |
| +2 | K181150 | ProtekDuo Mini Veno-Venous Cannula Set | Cardiacassist, Inc. | 2018 | — |
| +4 | 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 |
|---|---|---|
| 1993 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K081820 | Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FRSummary page 4…r catheter, cannula, or tubing. (21 CFR 870.4210, Product Code DWF) Predicate Devices Avalon (Maquet) Elite Bi-Caval Dual Lumen Catheter (K081820) TandemHeart Venous Cannula (K133236) Device Description The TandemHeart Veno-Venous Cannula Set consists of two comp… | 2008 |
| * | K133236 | Tandemheart Femoral Venous Cannula SetSummary page 4…tubing. (21 CFR 870.4210, Product Code DWF) Predicate Devices Avalon (Maquet) Elite Bi-Caval Dual Lumen Catheter (K081820) TandemHeart Venous Cannula (K133236) Device Description The TandemHeart Veno-Venous Cannula Set consists of two components: a 29 Fr. Dual lumen… | 2014 |
What descends from it? (7)
3 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)
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 13 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K160257 (Cardiacassist, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K081820.
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. 2014, 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 TandemHeart Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
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/K140999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140999: Tandemheart Veno-Venous Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140999
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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