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. · QHW Single Lumen Ecmo Cannula
Cleared on Apr 19, 2024 as substantially equivalent to K201057 (Medtronic, Inc., 2022) and 1 other predicate after a 53-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Apr 19, 2024
- Review
- 53 days
- Class
- Class II
- Product code
- QHW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003288 (2001). 11 ancestors in all, the oldest K840001 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK003288 Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
- 4 generations backK081820 Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR…Avalon Laboratories, LLC · 2008
- 3 generations backK142673 Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2014
- 2 generations backK180453 Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2018
- 1 generation backK201100 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2021
- This deviceK240534 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003288 | Origen Dual Lumen Catheter | Origen Biomedical, Inc. | 2001 | — |
| −4 | K081820 | Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR… | Avalon Laboratories, LLC | 2008 | — |
| −3 | K142673 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2014 | — |
| −2 | K180453 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2018 | — |
| −1 | K201100 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2021 | — |
| 0 (this device) | 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 |
| 2022 | 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 QHW? 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 QHW device
- #1 K251831 Bio-Medicus Life Support Catheter and Introducerscore 11.9 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K201057 | Bio-Medicus Life Support Catheter and IntroducerSummary page 4…Product Code: DWF Classification: II Predicate Device: Bio-Medicus Life Support™ Catheter and Introducer (K201057, K201100) Medtronic Cardiac Surgery Bio-Medicus Life Support Catheter – Luer Cap Material C… | 2022 |
| * | K201100 | Bio-Medicus Life Support Catheter and IntroducerSummary page 4…ification: II Predicate Device: Bio-Medicus Life Support™ Catheter and Introducer (K201057, K201100) Medtronic Cardiac Surgery Bio-Medicus Life Support Catheter – Luer Cap Material Change Special 510(k) KXXXXXX D… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K201057.
How does its category compare?
All QHW devicesQHW Single Lumen Ecmo Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QHW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QHW
Too few QHW 510(k)s in any year since 2007 to give a median.
Recalls per year · QHW
No recall names QHW since 2007.
Adverse event reports per year · QHW
7in 2025
MAUDE reports naming product code QHW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Cardiopulmonary Bypass (CPB): 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…
Read the full statement (161 words)
Cardiopulmonary Bypass (CPB):
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.
Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS):
The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240534: 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/K240534
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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