# K251831: Bio-Medicus Life Support Catheter and Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jan 15, 2026 after 216 days
- Product code: QHW (Single Lumen Ecmo Cannula)
- Device class: 2
- Regulation: 21 CFR 870.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003288 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201057: Bio-Medicus Life Support Catheter and Introducer, Medtronic, Inc. (2022) Summary page 5.
- K201100: Bio-Medicus Life Support Catheter and Introducer, Medtronic, Inc. (2021) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K251831
Methodology: https://510kreport.com/methodology