Data / Medical devices / United States / Vapotherm Inc.
Vapotherm Inc.: FDA-registered device maker in Exeter, NH, United States, 7 510(k) clearances
Vapotherm Inc. is registered with the FDA (registration 3012971441) in Exeter, NH, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 13, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012971441
- Address
- 100 Domain Dr, Exeter, NH, United States, 03833
- Owner or operator
- VAPOTHERM, INC. (9038880)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 27, 2008
- Registered through
- 2026
- Brand names listed
- AAA-2, FELIX-1, HVT 2, PF-ADPC-LOW, Precision Flow Heliox, ProSoft Nasal Cannula, Vapotherm Transfer Unit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Breathing System (Calibrated) | CBD | 2 | Specification developer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Specification developer | accessdata.fda.gov |
| High Flow/High Velocity Humidified Oxygen Delivery Device | QAV | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Specification developer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 13, 2026 | K254078 | HVT 2.0 | BTT | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
| December 13, 2022 | K221318 | HVT 2.0 | QAV | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
| October 28, 2022 | K220869 | Vapotherm Aerosol Adapter AAA-2 | CAF | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
| August 25, 2021 | K203357 | HVT 2.0 | BTT | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
| April 10, 2018 | DEN170001 | Precision Flow® HVNI | QAV | Unknown | Vapotherm, Inc. | accessdata.fda.gov |
| October 7, 2011 | K111640 | PRECISION FLOW(R) - HELIOX | BTT | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
| July 17, 2008 | K072845 | PRECISION FLOW | BTT | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 16, 2022 | 91579 | Class II | Ongoing | Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW | There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout. | accessdata.fda.gov |
| August 13, 2014 | 69116 | Class II | Terminated | Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administrat | Disposable Patient Circuit that allows water to leak into the center gas lumen | accessdata.fda.gov |
Compare with other makers
- All makers of Bottle, Collection, Breathing System (Calibrated)
- All makers of High Flow/High Velocity Humidified Oxygen Delivery Device
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Regulator, Pressure, Gas Cylinder
- All makers of Cannula, Nasal, Oxygen
Updated April 13, 2026. 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.