Data / Medical devices / High Flow/High Velocity Humidified Oxygen Delivery Device
High Flow/High Velocity Humidified Oxygen Delivery Device (QAV): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make High Flow/High Velocity Humidified Oxygen Delivery Device (product code QAV, Class 2, 21 CFR 868.5454). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on January 27, 2023, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- QAV
- Device class
- 2
- Regulation
- 868.5454
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| Mexico | 3 |
| United States | 1 |
| New Zealand | 1 |
Makers of High Flow/High Velocity Humidified Oxygen Delivery Device
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Vapotherm Inc. | Exeter, NH, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | December 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Baja Fur S.A. de C.V. | Tijuana Baja California, Mexico | Manufacturer | 1 | December 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Fisher & Paykel Healthcare, Ltd. | EAST TAMAKI Auckland, New Zealand | Complaint file establishment, Manufacturer | 1 | January 27, 2023 | 0 | 1 | 0 | api.fda.gov |
| Fisher & Paykel Healthcare S.a.de C.V. | Tijuana, Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher & Paykel Healthcare S.A.de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.