Vapotherm, Inc.
FDA Regulatory Profile
Vapotherm, Inc. appears in FDA public data with 9 recalls, 13 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1272-2023, Class II) was initiated on December 16, 2022. Its most recent 510(k) clearance was granted on April 13, 2026.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 13
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1272-2023 | Class II | Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW | December 16, 2022 |
| Z-2705-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precisio | August 13, 2014 |
| Z-2706-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flo | August 13, 2014 |
| Z-2704-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compati | August 13, 2014 |
| Z-2700-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow | August 13, 2014 |
| Z-2702-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow | August 13, 2014 |
| Z-2699-2014 | Class II | Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow s | August 13, 2014 |
| Z-2703-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow sy | August 13, 2014 |
| Z-2701-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision | August 13, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254078 | HVT 2.0 | April 13, 2026 |
| K221318 | HVT 2.0 | December 13, 2022 |
| K220869 | Vapotherm Aerosol Adapter AAA-2 | October 28, 2022 |
| K203357 | HVT 2.0 | August 25, 2021 |
| K191010 | Palladium High Flow Therapy System | October 10, 2019 |
| DEN170001 | Precision Flow® HVNI | April 10, 2018 |
| K111640 | PRECISION FLOW(R) - HELIOX | October 7, 2011 |
| K103316 | FLOWREST | February 8, 2011 |
| K072845 | PRECISION FLOW | July 17, 2008 |
| K070056 | VAPOTHERM MODEL# 2000I AND 2000H | April 13, 2007 |
| K042245 | VAPOTHERM MODEL#2000I, 200H | August 30, 2004 |
| K013486 | VAPOTHERM 2000H | May 30, 2003 |
| K000401 | VAPOTHERM, MODEL 2000I | August 24, 2000 |