510(k) · Cleared
Recalled · Class II · 2026Medtronic Bio-Medicus Adult Cannula Kit
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 Jan 15, 2016 as substantially equivalent to K150567 (Medtronic, Inc., 2015) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 15, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003288 (2001). 6 ancestors in all, the oldest K884129 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK003288 Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
- 2 generations backK081820 Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR…Avalon Laboratories, LLC · 2008
- 1 generation backK142673 Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2014
- This deviceK153598 Medtronic Bio-Medicus Adult Cannula KitMedtronic, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK180456 Bio-Medicus Adult Cannulae KitMedtronic, Inc. · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K180456Bio-Medicus Adult Cannulae KitMedtronic, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003288 | Origen Dual Lumen Catheter | Origen Biomedical, Inc. | 2001 | — |
| −2 | K081820 | Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR… | Avalon Laboratories, LLC | 2008 | — |
| −1 | K142673 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2014 | — |
| 0 (this device) | K153598 | Medtronic Bio-Medicus Adult Cannula Kit | Medtronic, Inc. | 2016 | — |
| +1 | K180456 | Bio-Medicus Adult Cannulae Kit | Medtronic, Inc. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K150567 | Medtronic Bio-Medicus Cannula Insertion KitSummary page 4…ascular Regulation: 21 CFR 870.4210 Product Code: DWF Predicate Device: Medtronic Bio-Medicus™ Insertion Kit (K150567) and Medtronic Bio- Medicus™ Cannula Adult Cannula and Introducer (K142673) Device Description This kit is a combinatio… | 2015 |
| * | K142673 | Bio-Medicus Adult Cannulae and IntroducerSummary page 4…Product Code: DWF Predicate Device: Medtronic Bio-Medicus™ Insertion Kit (K150567) and Medtronic Bio- Medicus™ Cannula Adult Cannula and Introducer (K142673) Device Description This kit is a combination of the following two sets of devices: Bio-Medicus Adult Cannula and I… | 2014 |
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 |
|---|---|---|---|
| K180456 | Bio-Medicus Adult Cannulae Kit | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2026 | Class II | Z-2739-2026 | Packaging | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K180456 (Medtronic, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K150567.
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. 2016, 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-Medicus™ cannulae (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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153598 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153598: Medtronic Bio-Medicus Adult Cannula Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153598
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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