# K180474: TNI softFlow 50

- Pathway: 510(k) (Traditional)
- Applicant: Tni Medical AG
- Decided: Oct 18, 2018 after 238 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913368 (1992). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131895: Airvo 2 Humidifier, Myairvo 2 Humidifier, Fisher & Paykel Healthcare, Ltd. (2013) Summary page 4.

## Indications for use
The TNI softFlow 50 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. The TNI softFlow 50 is for adult patients in hospitals and long-term care facilities. The flow may be from 10-50 L/min. The TNI softFlow 50 is not indicated for life support measures.

Source page: https://510kreport.com/device/K180474
Methodology: https://510kreport.com/methodology