# K221318: HVT 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Vapotherm, Inc.
- Decided: Dec 13, 2022 after 221 days
- Product code: QAV (High Flow/High Velocity Humidified Oxygen Delivery Device)
- Device class: 2
- Regulation: 21 CFR 868.5454
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170001 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170001: Precision Flow® HVNI, Vapotherm, Inc. (2018) Summary page 4.

## Indications for use
The HVT 2.0 system provides high velocity nasal insufflation (HVNI) with simultaneous warmed and humidified respiratory gas delivery to augment breathing of spontaneously breathing adult and pediatric patients (5 kg and up) suffering from respiratory distress and/or hypoxemia in the hospital setting, via a small bore nasal cannula. HVT 2.0 is not intended to provide total ventilatory requirements of the patient and not for use during field transport. The flow rates may be from 5 to 45 liters per minute (BTPS).

Source page: https://510kreport.com/device/K221318
Methodology: https://510kreport.com/methodology