HVT 2.0— 510(k) K254078
Substantially EquivalentVapotherm, Inc.
FDA 510(k) clearance K254078 for HVT 2.0, Substantially Equivalent on 2026-04-13. Applicant: Vapotherm, Inc.. Device class: 2.
Summary
Vapotherm's HVT 2.0 is filed under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 868.5450. It came in as a Traditional 510(k), and Anesthesiology is both the classification panel and the review panel.
Vapotherm filed from Exeter, New Hampshire. Review took 116 calendar days (December 18, 2025 to April 13, 2026).
Clearance details
- Applicant
- Vapotherm, Inc.
- Product code
- Product code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Exeter, NH, US
Recent devices under product code BTT
view all- K262268 — Optiflow Oxygen Kit (AA484J)
- K251448 — FL-10000U Respiratory Humidifier
- K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP
- K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
- K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
More clearances from Vapotherm, Inc.
view allAdverse events under product code BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.