Hvt 2.0
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- HVT 2.0 EUDAMEDVapotherm FDA UDI
- Generic Name
- Professional high-flow respiratory unit, humidifying, manual FDA UDIElectrical mains power cable FDA UDI
- Device Name
- HVT 2.0 EUDAMEDHVT 2.0 UKIT, NIST Version FDA UDIHVT 2.0 ADPC FDA UDIHVT 2.0 Unit, Non-OAM FDA UDIHVT 2.0 Aerogen Aerosol Adapter FDA UDI
- Model / Reference
- HVT-UKIT-NIST EUDAMEDFDA UDIHVT-ADPC EUDAMEDFDA UDIHVT20-UNIT EUDAMEDFDA UDIAAA-2 EUDAMEDFDA UDIHVT 2.0 EUDAMED
- Description
- HVT 2.0 UKIT, NIST Version FDA UDIHVT 2.0 ADPC FDA UDIHVT 2.0 Unit, Non-OAM FDA UDIHVT 2.0 Aerogen Aerosol Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841737105473 EUDAMEDFDA UDI00841737104001 EUDAMEDFDA UDI00841737103219 EUDAMEDFDA UDI00841737103936 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841737102021UN EUDAMED
- Direct Marketing DI
- 00841737104001 EUDAMED00841737103219 EUDAMED00841737103936 EUDAMED
- 510(k) Number
- K221318 FDA 510(k)
- FDA Product Code
- QAV FDA 510(k)FDA UDIBTT FDA UDI
- EMDN Code
- R040201 TRACHEOSTOMY HUMIDIFIERS EUDAMEDR9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Professional high-flow respiratory unit, humidifying, manual FDA UDIElectrical mains power cable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5454 FDA 510(k)
- Regulation Number
- 868.5454 FDA 510(k)FDA UDI868.5450 FDA UDI
- Market of Registration
- Austria EUDAMEDBelgium EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The HVT 2.0 is a High Flow/High Velocity Humidified Oxygen Delivery Device, designed to provide precise and efficient humidified oxygen therapy. It operates by delivering high-velocity airflow to rapidly heat and humidify inhaled gases, ensuring optimal respiratory support for patients requiring advanced ventilation assistance.
This device is intended for use in clinical settings such as operating rooms and intensive care units, where controlled oxygen delivery is critical. Supplied as a reusable medical device, it must be sterilized between uses and adheres to FDA 510(k) clearance and MDR compliance. The HVT 2.0 is classified under device class 2 and is regulated under the U.S. regulation number 868.5454, with specific registration numbers and FEI numbers listed for tracking.
Frequently asked questions
What clinical environments is the HVT 2.0 primarily intended for, and why does this matter for my facility?
The HVT 2.0 is designed for use in high-precision oxygen delivery settings like operating rooms and intensive care units, where controlled and efficient humidified oxygen therapy is critical. This matters for your facility because it ensures patients requiring advanced ventilation support—such as those undergoing surgery or critical care—receive consistent, high-velocity airflow that rapidly heats and humidifies inhaled gases, reducing the risk of airway complications like dryness or irritation.
Is the HVT 2.0 a single-use device, or does it require reprocessing between patients, and if so, how?
The HVT 2.0 is a reusable medical device, so it must be sterilized between uses to maintain safety and hygiene standards. This is important because it allows for cost-effective use across multiple patients while ensuring compliance with FDA and MDR regulations, which mandate proper sterilization procedures for reusable devices in clinical settings.
What regulatory pathways does the HVT 2.0 follow, and how does this impact its use in my facility?
The HVT 2.0 follows the FDA 510(k) clearance pathway and adheres to the EU Medical Device Regulation (MDR), with a classification under device class 2. This means it has undergone rigorous review by the FDA’s Anesthesiology Advisory Committee and is regulated under U.S. code 868.5454, ensuring it meets established safety and performance standards for high-flow oxygen delivery systems in operating rooms and ICUs.
Are there specific tracking or registration numbers associated with the HVT 2.0 that my facility should be aware of?
Yes, the HVT 2.0 includes multiple FEI numbers (e.g., 3000210616, 3023209222) and registration numbers (e.g., 3015928685, 9611451) for tracking and compliance purposes. These identifiers help ensure traceability for regulatory audits, inventory management, and recall coordination, which is essential for maintaining a well-documented medical device inventory in your facility.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221318 | Class II | Active |
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Manufacturer
- Manufacturer
- Vapotherm, Inc.
Sources (9)
- FDA 510(k) K221318 24 fields · synced Sep 18, 2026
- FDA UDI 2b1b4c35-7f0a-4557-b16f-4073dcc3cb5f 33 fields · synced May 29, 2026
- FDA UDI 387c2fae-7f58-4d21-897e-9f2b8e4f5868 33 fields · synced May 30, 2026
- FDA UDI a52b1322-cc33-43f6-85ca-c9ea408b00b1 33 fields · synced May 30, 2026
- FDA UDI d20d4e21-9185-4d26-a235-4a8a741a3a57 33 fields · synced May 30, 2026
- EUDAMED 83180a9f-d1bd-437f-a4d5-b3782a81a0ee 61 fields · synced Jul 9, 2026
- EUDAMED 564b43b1-163c-4355-afe2-624f31aa64be 61 fields · synced Jul 9, 2026
- EUDAMED 9d24710d-f2b5-4061-8221-0dddbbe8a6f5 61 fields · synced Jul 10, 2026
- EUDAMED 35eedf74-067a-4931-91a1-ec56729d4391 61 fields · synced Jul 10, 2026