# K191935: Nautilus Smart ECMO Module

- Pathway: 510(k) (Traditional)
- Applicant: Mc3 Incorporated
- Decided: Apr 9, 2020 after 265 days
- Product code: BYS (Oxygenator, Long Term Support Greater Than 6 Hours)
- Device class: 2
- Regulation: 21 CFR 870.4100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 81 FR 7451, Feb. 12, 2016: named in the summary without a submission number

## Most influential descendants
- K232767: Nautilus VF ECMO Oxygenator (2023), 0 descendants of its own

## Recalls of this device
- Oct 11, 2023 · Class II · Z-1310-2024: May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be 
- Oct 11, 2023 · Class II · Z-1309-2024: May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be 

## Indications for use
The Nautilus(tm) 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. The Nautilus(tm) Smart ECMO Module 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 and display.

Source page: https://510kreport.com/device/K191935
Methodology: https://510kreport.com/methodology