# K203357: HVT 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Vapotherm, Inc.
- Decided: Aug 25, 2021 after 282 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.
1 later device descends 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)
- K191010: Palladium High Flow Therapy System, Vapotherm, Inc. (2019) Summary page 4.

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

## Indications for use
The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult patients and pediatric patients (5 kg and up). The device is intended to be used in hospital, sub-acute facility, and home-use settings.

Source page: https://510kreport.com/device/K203357
Methodology: https://510kreport.com/methodology