Company · US
Vapotherm, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2026. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (1 in 12 months)
10recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 13, 2026 | K254078 | HVT 2.0 Vapotherm, Inc. | BTT |
| Dec 13, 2022 | K221318 | HVT 2.0 Vapotherm, Inc. | QAV |
| Oct 28, 2022 | K220869 | Vapotherm Aerosol Adapter AAA-2 Vapotherm, Inc. | CAF |
| Aug 25, 2021 | K203357 | HVT 2.0 Vapotherm, Inc. | BTT |
| Oct 10, 2019 | K191010 | Palladium High Flow Therapy System Vapotherm, Inc. | BTT |
| Apr 10, 2018 | DEN170001 | Precision Flow® HVNI Vapotherm, Inc. | QAV |
| Oct 7, 2011 | K111640 | PRECISION FLOW(R) - HELIOX Vapotherm, Inc. | BTT |
| Feb 8, 2011 | K103316 | FLOWREST Vapotherm, Inc. | BTT |
| Jul 17, 2008 | K072845 | PRECISION FLOW Vapotherm, Inc. | BTT |
| Apr 13, 2007 | K070056 | VAPOTHERM MODEL# 2000I AND 2000H Vapotherm, Inc. | BTT |
| Aug 30, 2004 | K042245 | VAPOTHERM MODEL#2000I, 200H Vapotherm, Inc. | BTT |
| May 30, 2003 | K013486 | VAPOTHERM 2000H Vapotherm, Inc. | BTT |
| Aug 24, 2000 | K000401 | VAPOTHERM, MODEL 2000I Vapotherm, Inc. | BTT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2023 | Vapotherm Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW Open, Classified |
BTT | K111640 |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PF-NODPC-Low.
For use with the Precision Flow system and Ikaria INOmax DSIR
System.
This DPC allows clinicians to administer nitric oxide non-inva Terminated |
BTT | K072845 |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PFHDPC-Low.
For use with the Heliox Precision Flow system
Precision Flow" is intended for use to add warm moisture to breathing gases from an exter Terminated |
BTT | K072845 |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PF-E-DPC-Low.
PF-DPC-Low packaged with compatible cannulas for evaluation of the
Precision Flow system Terminated |
BTT | K072845 |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PF-DPC-Low.
For use with the Precision Flow system
Precision Flow" is intended for use to add warm moisture to breathing gases from an external sour Terminated |
BTT | K072845 |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PFNODPC-High.
For use with the Precision Flow system and Ikaria INOmax DSIR
System.
This DPC allows clinicians to administer nitric oxide non-invas Terminated |
BTT | K072845 |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PFH-DPC-High. For use with the Heliox Precision Flow system
Precision Flow" is intended for use to add warm moisture to breathing gases from an ext Terminated |
BTT | K072845 |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PF-E-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 Terminated |
BTT | K072845 |
| Sep 25, 2014 | Vapotherm, Inc. 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 s Terminated |
BTT | K072845 |
| Jan 19, 2006 | Vapotherm, Inc. Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***. Terminated |
BTT | None listed |