# K232767: Nautilus VF ECMO Oxygenator

- Pathway: 510(k) (Special)
- Applicant: Mc3, Inc.
- Decided: Oct 4, 2023 after 23 days
- Product code: BYS (Oxygenator, Long Term Support Greater Than 6 Hours)
- 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: 1 generation back to K191935 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191935: Nautilus Smart ECMO Module, Mc3 Incorporated (2020) Summary page 4.

## Indications for use
The Nautilus VF ECMO Oxygenator with integrated heat exchanger is intended to provide assisted long-term extracorporeal circulation and physiologic gas exchange (oxygenation and carbon dioxide removal) of the patient's blood for up to 48 hours in adult and pediatric adolescent 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. The integrated heat exchanger is intended to heat or cool the blood as needed during use. Integrated fluid path pressure, temperature, and oxygen saturation monitoring is achieved by built-in sensor modules.

Source page: https://510kreport.com/device/K232767
Methodology: https://510kreport.com/methodology