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 Jan 14, 2022 after a 633-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jan 14, 2022
- Review
- 633 days
- Class
- Class II
- Product code
- QHW
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK201057 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2022
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K201057 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2022 | — |
| +1 | K251831 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2026 | — |
| +1 | K240534 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2024 | — |
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 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
- #2 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.
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?
- Of its descendants, K251831 (Medtronic, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QHW devicesQHW Single Lumen Ecmo Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
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 failure 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/K201057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201057: 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/K201057
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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