Vapotherm, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Vapotherm, Inc. - FDA 510(k) Cleared Devices
Recent clearances: HVT 2.0, HVT 2.0, Vapotherm Aerosol Adapter AAA-2
13
Total
12
Cleared
1
Denied
Vapotherm, Inc. has 12 FDA 510(k) cleared anesthesiology devices. Based in Annapolis, US.
Latest FDA clearance: Apr 2026. Active since 2000.
Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Third Party Review Group, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Vapotherm, Inc.
13 devices
Cleared
Apr 13, 2026
HVT 2.0
Anesthesiology
116d
Cleared
Dec 13, 2022
HVT 2.0
Anesthesiology
221d
Cleared
Oct 28, 2022
Vapotherm Aerosol Adapter AAA-2
Anesthesiology
217d
Cleared
Aug 25, 2021
HVT 2.0
Anesthesiology
282d
Cleared
Oct 10, 2019
Palladium High Flow Therapy System
Anesthesiology
177d
Not Cleared
Apr 10, 2018
Precision Flow® HVNI
Anesthesiology
462d
Cleared
Oct 07, 2011
PRECISION FLOW(R) - HELIOX
Anesthesiology
116d
Cleared
Feb 08, 2011
FLOWREST
Anesthesiology
90d
Cleared
Jul 17, 2008
PRECISION FLOW
Anesthesiology
287d
Cleared
Apr 13, 2007
VAPOTHERM MODEL# 2000I AND 2000H
Anesthesiology
98d
Cleared
Aug 30, 2004
VAPOTHERM MODEL#2000I, 200H
Anesthesiology
11d
Cleared
May 30, 2003
VAPOTHERM 2000H
Anesthesiology
588d