510(k) · Cleared
Recalled · Class II · 2017Bio-Medicus Pediatric Cannula and Introducers
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 Mar 25, 2015 as substantially equivalent to K872033 (Bio Medicus, Inc., 1987) and 1 other predicate after a 149-day review. Its family tree reaches back 2 generations to 1984. 3 later devices descend from it. It has been recalled once.
- Decided
- Mar 25, 2015
- Review
- 149 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K840001 (1984). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK840001 Arterial Cannula Straight Beveled TipDlp, Inc. · 1984 · Recalled
- 1 generation backK024069 One Piece Pediatric Arterial Cannula, Model: 77006, 77106Medtronic Vascular · 2003 · Recalled
- This deviceK143083 Bio-Medicus Pediatric Cannula and IntroducersMedtronic, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK201100 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK251831 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK240534 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See all- K201100Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2021 · cites it directly2descendants
- K251831Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2026 · 2 generations on0descendants
- K240534Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K840001 | Arterial Cannula Straight Beveled Tip | Dlp, Inc. | 1984 | 1 |
| −1 | K024069 | One Piece Pediatric Arterial Cannula, Model: 77006, 77106 | Medtronic Vascular | 2003 | 2 |
| 0 (this device) | K143083 | Bio-Medicus Pediatric Cannula and Introducers | Medtronic, Inc. | 2015 | — |
| +1 | K201100 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2021 | — |
| +2 | K251831 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2026 | — |
| +2 | K240534 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K872033 | Bio-Medicus Cannula-TubingSummary page 4…ypass vascular catheter, cannula, or tubing Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Class I1, 21 CFR 870.4210 DWF Bio-Medicus™ Cannula-Tubing (K872033) DLP Pediatric™ One-Piece Arterial Cannulae (K024069) The pediatric venous cannulae consist of a polyurethane wirewound body wit… | 1987 |
| * | K024069 | One Piece Pediatric Arterial Cannula, Model: 77006, 77106Summary page 4…Cannula and Tubing, Vascular, Cardiopulmonary Bypass Class I1, 21 CFR 870.4210 DWF Bio-Medicus™ Cannula-Tubing (K872033) DLP Pediatric™ One-Piece Arterial Cannulae (K024069) The pediatric venous cannulae consist of a polyurethane wirewound body with a multi-port distal tip. All pediatric venous cannu… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201100 | Bio-Medicus Life Support Catheter and Introducer | 2021 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2017 | Class II | Z-0640-2018 | Under Investigation by firm | Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 18.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K201100 (Medtronic, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K872033.
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?
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. These products
are 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/K143083 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143083: Bio-Medicus Pediatric Cannula and Introducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143083
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