510(k) · Cleared
ClearedTandemheart Femoral Arterial Cannula Set
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 May 30, 2012 as substantially equivalent to K924642 (Medtronic Bio-Medicus, Inc., 1993) after a 97-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- May 30, 2012
- Review
- 97 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924642 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK924642 Medtronic Bio-Medicus Femoral Cannula/IntroducerMedtronic Bio-Medicus, Inc. · 1993 · Recalled
- This deviceK120543 Tandemheart Femoral Arterial Cannula SetCardiacassist, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK133293 15 FR. Tandemheart Arterial CannulaCardiacassist, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K13329315 FR. Tandemheart Arterial CannulaCardiacassist, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924642 | Medtronic Bio-Medicus Femoral Cannula/Introducer | Medtronic Bio-Medicus, Inc. | 1993 | 1 |
| 0 (this device) | K120543 | Tandemheart Femoral Arterial Cannula Set | Cardiacassist, Inc. | 2012 | — |
| +1 | K133293 | 15 FR. Tandemheart Arterial Cannula | Cardiacassist, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K924642 | Medtronic Bio-Medicus Femoral Cannula/IntroducerSummary page 1…r catheter, cannula, or tubing. (21 CFR 870.4210, Product Code DWF) Predicate Device Medtronic Bio-Medicus Femoral Cannula and Introducer (K924642) Device Description The TandemHeart Femoral Arterial Cannula Set consists of two components, as shown in Figure 1: a 17 Fr. Fem… | 1993 |
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 |
|---|---|---|---|
| K133293 | 15 FR. Tandemheart Arterial Cannula | 2014 | 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?
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. 2012, 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 Femoral Arterial Cannula and Introducer is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment for a duration of six hours or less. The cannula introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120543: Tandemheart Femoral Arterial Cannula Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120543
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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