510(k) · Cleared
ClearedMedtronic Bio-Medicus Cannula Insertion 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 Apr 9, 2015 as substantially equivalent to K924643 (Medtronic Bio-Medicus, Inc., 1992) after a 34-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Apr 9, 2015
- Review
- 34 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924643 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK924643 Medtronic Bio-Medicus Cannula Insertion KitMedtronic Bio-Medicus, Inc. · 1992
- This deviceK150567 Medtronic Bio-Medicus Cannula Insertion KitMedtronic, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK153598 Medtronic Bio-Medicus Adult Cannula KitMedtronic, Inc. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK190557 Bio-Medicus Insertion KitMedtronic, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK180456 Bio-Medicus Adult Cannulae KitMedtronic, Inc. · 2018 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924643 | Medtronic Bio-Medicus Cannula Insertion Kit | Medtronic Bio-Medicus, Inc. | 1992 | — |
| 0 (this device) | K150567 | Medtronic Bio-Medicus Cannula Insertion Kit | Medtronic, Inc. | 2015 | — |
| +1 | K153598 | Medtronic Bio-Medicus Adult Cannula Kit | Medtronic, Inc. | 2016 | 1 |
| +1 | K190557 | Bio-Medicus Insertion Kit | Medtronic, Inc. | 2019 | 1 |
| +2 | K180456 | Bio-Medicus Adult Cannulae Kit | Medtronic, Inc. | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K924643 | Medtronic Bio-Medicus Cannula Insertion KitSummary page 4…ascular Regulation: 21 CFR 870.4210 Product Code: DWF Predicate Device: Medtronic Bio‐Medicus™ Cannula Insertion Kit (K924643) Device Description Bio‐Medicus™ Insertion Kits contains the necessary components to achieve insertion of a Bio‐ Medicus™ cannu… | 1992 |
What descends from it? (3)
2 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?
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. 2015, 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?
This kit is intended for use by trained physicians only, to assist in vessel cannulation for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This kit is intended for use for up to 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150567: Medtronic Bio-Medicus Cannula Insertion Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150567
Report an extraction error
Are you the manufacturer?
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