# K254078: HVT 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Vapotherm, Inc.
- Decided: Apr 13, 2026 after 116 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: 10 generations back to K913368 (1992). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072845: Precision Flow, Vapotherm, Inc. (2008) Summary page 5.
- K203357: HVT 2.0, Vapotherm, Inc. (2021) Summary page 5.

## Indications for use
The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing neonate/infant, pediatric and adult patients. The device is intended to be used in hospital and sub-acute facility settings. HVT 2.0 is not for use during field transport. The flow rates may be from 2 to 45 liters per minute (BTPS).

Source page: https://510kreport.com/device/K254078
Methodology: https://510kreport.com/methodology