Vapotherm, Inc.

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
12
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1272-2023Class IILow Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOWDecember 16, 2022
Z-2700-2014Class IIVapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow August 13, 2014
Z-2704-2014Class IIVapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatiAugust 13, 2014
Z-2701-2014Class IIVapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox PrecisionAugust 13, 2014
Z-2699-2014Class IIVapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow sAugust 13, 2014
Z-2702-2014Class IIVapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow August 13, 2014
Z-2705-2014Class IIVapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox PrecisioAugust 13, 2014
Z-2703-2014Class IIVapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow syAugust 13, 2014
Z-2706-2014Class IIVapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision FloAugust 13, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K221318HVT 2.0December 13, 2022
K220869Vapotherm Aerosol Adapter AAA-2October 28, 2022
K203357HVT 2.0August 25, 2021
K191010Palladium High Flow Therapy SystemOctober 10, 2019
DEN170001Precision Flow® HVNIApril 10, 2018
K111640PRECISION FLOW(R) - HELIOXOctober 7, 2011
K103316FLOWRESTFebruary 8, 2011
K072845PRECISION FLOWJuly 17, 2008
K070056VAPOTHERM MODEL# 2000I AND 2000HApril 13, 2007
K042245VAPOTHERM MODEL#2000I, 200HAugust 30, 2004
K013486VAPOTHERM 2000HMay 30, 2003
K000401VAPOTHERM, MODEL 2000IAugust 24, 2000