510(k) · Cleared
ClearedBio-Medicus Life Support Catheter 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 Jul 15, 2021 as substantially equivalent to K142673 (Medtronic, Inc., 2014) and 2 other predicates after a 447-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it.
- Decided
- Jul 15, 2021
- Review
- 447 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K003288 (2001). 9 ancestors in all, the oldest K840001 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK003288 Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
- 3 generations backK081820 Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR…Avalon Laboratories, LLC · 2008
- 2 generations backK142673 Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2014
- 1 generation backK180453 Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2018
- This deviceK201100 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK251831 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK240534 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003288 | Origen Dual Lumen Catheter | Origen Biomedical, Inc. | 2001 | — |
| −3 | K081820 | Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR… | Avalon Laboratories, LLC | 2008 | — |
| −2 | K142673 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2014 | — |
| −1 | K180453 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2018 | — |
| 0 (this device) | K201100 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2021 | — |
| +1 | K251831 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2026 | — |
| +1 | K240534 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 2003 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K142673 | Bio-Medicus Adult Cannulae and IntroducerSummary page 4…ation: Class II Regulation Number: CFR 870.4210 Product Code: DWF Name of Predicate Device: Bio-Medicus Adult Cannulae and Introducer (K142673) Bio-Medicus Pediatric Arterial and Femoral Cannula (K143083) Bio-Medicus Adu… | 2014 |
| * | K143083 | Bio-Medicus Pediatric Cannula and IntroducersSummary page 4…DWF Name of Predicate Device: Bio-Medicus Adult Cannulae and Introducer (K142673) Bio-Medicus Pediatric Arterial and Femoral Cannula (K143083) Bio-Medicus Adult Cannulae and Introducer (K180453) Device Description: The Bio-Medicu… | 2015 |
| * | K180453 | Bio-Medicus Adult Cannulae and IntroducerSummary page 4…cer (K142673) Bio-Medicus Pediatric Arterial and Femoral Cannula (K143083) Bio-Medicus Adult Cannulae and Introducer (K180453) Device Description: The Bio-Medicus Life Support catheter is a single-lumen catheter used to drain or reinfuse b… | 2018 |
What descends from it? (2)
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K251831 (Medtronic, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142673.
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. 2021, 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?
Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately-sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201100: Bio-Medicus Life Support Catheter 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/K201100
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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