# K191010: Palladium High Flow Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Vapotherm, Inc.
- Decided: Oct 10, 2019 after 177 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: 8 generations back to K913368 (1992). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103316: Flowrest, Vapotherm, Inc. (2011) Summary page 4.

## Most influential descendants
- K203357: HVT 2.0 (2021), 1 descendant of its own
- K254078: HVT 2.0 (2026), 0 descendants of its own

## Indications for use
The Palladium High Flow Therapy System is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult and pediatric patients weighing at least 3.5 kg within hospital, sub-acute and homecare settings.

Source page: https://510kreport.com/device/K191010
Methodology: https://510kreport.com/methodology