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FDA 510(k)

HVT 2.0

K-Number: K254078 · 2026-04-13

ApplicantVapotherm, Inc.
Decision Date2026-04-13
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HVT 2.0 is a medical device manufactured by Vapotherm, Inc.. It received FDA 510(k) clearance on 2026-04-13 under approval number K254078. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HVT 2.0?

HVT 2.0 is a medical device that received FDA 510(k) clearance on 2026-04-13. It is manufactured by Vapotherm, Inc.. The 510(k) number is K254078.

When was HVT 2.0 approved by the FDA?

HVT 2.0 received FDA 510(k) clearance on 2026-04-13, under approval number K254078.

What company makes HVT 2.0?

HVT 2.0 is manufactured by Vapotherm, Inc..

What is the FDA product code for HVT 2.0?

The FDA product code for HVT 2.0 is BTT.

Other Devices by Vapotherm, Inc.

DEN170001Precision Flow® HVNI K191010Palladium High Flow Therapy System K203357HVT 2.0 K221318HVT 2.0 K220869Vapotherm Aerosol Adapter AAA-2

Related Devices (Code: BTT)

K160764AirLife Autofill Humidification ChamberCarefusion 2200, Inc. K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASEFlexicare Medical Limited. K152029HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K161719Salter Labs Bubble HumidifierSalter Labs K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K162242Comfort Flo Humidification SystemTeleflexmedical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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