510(k) · Cleared
ClearedBio-Medicus Adult Cannulae and Introducer
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 Nov 18, 2014 as substantially equivalent to K884129 (Bio Medicus, Inc., 1988) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 2001. 9 later devices descend from it.
- Decided
- Nov 18, 2014
- Review
- 60 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003288 (2001). 3 ancestors in all, the oldest K884129 (1988). 9 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 deviceK142673 Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK180453 Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK203067 Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual…Qura S.R.L · 2021
- Descendant · cites it directly · 2 of its ownK201100 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK221353 Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual…Qura S.R.L · 2022
- Descendant · cites it directly · 1 of its ownK153598 Medtronic Bio-Medicus Adult Cannula KitMedtronic, Inc. · 2016 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K180453Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2018 · cites it directly6descendants
- K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F…Qura S.R.L · 2021 · 2 generations on2descendants
- K201100Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2021 · cites it directly2descendants
- K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F…Qura S.R.L · 2022 · 3 generations on1descendant
- K153598Medtronic Bio-Medicus Adult Cannula KitMedtronic, Inc. · 2016 · cites it directly1descendant
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) | K142673 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2014 | — |
| +1 | K180453 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2018 | — |
| +2 | K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen… | Qura S.R.L | 2021 | — |
| +1 | K201100 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2021 | — |
| +3 | K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula… | Qura S.R.L | 2022 | — |
| +1 | K153598 | Medtronic Bio-Medicus Adult Cannula Kit | Medtronic, Inc. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K884129 | Bio-Medicus Percutaneous Cannula & Introducer SetSummary page 4…ass II, 21 CFR 870.4210 Product Code: DWF Name of Predicate Devices: Medtronic Bio-Medicus Femoral Cannula and Introducer (K884129) Avalon Elite Bi-Caval Dual Lumen Catheter (K081820). Device Description: The adult venous and a… | 1988 |
| * | K081820 | Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FRSummary page 4…ces: Medtronic Bio-Medicus Femoral Cannula and Introducer (K884129) Avalon Elite Bi-Caval Dual Lumen Catheter (K081820). Device Description: The adult venous and arterial cannulae consist of a polyurethane wirewound body with a multi- port distal… | 2008 |
What descends from it? (9)
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 3 ancestors has a recall of any class.
- Of its descendants, K180453 (Medtronic, Inc., 2018) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K884129.
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?
These devices are to be used by a trained physician only. Cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-MedicusTM cannula (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula. This product is intended for use up to 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142673: Bio-Medicus Adult Cannulae and Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142673
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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