Vapotherm Inc.
Exeter, NH, US
Vapotherm Inc. appears in FDA device records in Exeter, NH. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Vapotherm Inc. between 2000 and 2026. The busiest year on record is 2011, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2011 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254078 | HVT 2.0 | BTT | Substantially Equivalent | |
| K221318 | HVT 2.0 | QAV | Substantially Equivalent | |
| K220869 | Vapotherm Aerosol Adapter AAA-2 | CAF | Substantially Equivalent | |
| K203357 | HVT 2.0 | BTT | Substantially Equivalent | |
| K191010 | Palladium High Flow Therapy System | BTT | Substantially Equivalent | |
| DEN170001 | Precision Flow® HVNI | QAV | Unknown | |
| K111640 | PRECISION FLOW(R) - HELIOX | BTT | Substantially Equivalent | |
| K103316 | FLOWREST | BTT | Substantially Equivalent | |
| K072845 | PRECISION FLOW | BTT | Substantially Equivalent | |
| K070056 | VAPOTHERM MODEL# 2000I AND 2000H | BTT | Substantially Equivalent | |
| K042245 | VAPOTHERM MODEL#2000I, 200H | BTT | Substantially Equivalent | |
| K013486 | VAPOTHERM 2000H | BTT | Substantially Equivalent | |
| K000401 | VAPOTHERM, MODEL 2000I | BTT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012971441 | 3012971441 | Vapotherm Inc. | 100 Domain Dr, Exeter, NH 03833 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1272-2023 | 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. | Class II | Open, Classified | |
| Z-2706-2014 | 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-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system | Water may leak into the center gas lumen of the Patient Circuit | Class II | Terminated | |
| Z-2705-2014 | 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 external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Disposable Patient Circuit that allows water to leak into the center gas lumen | Class II | Terminated | |
| Z-2704-2014 | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system | Disposable Patient Circuit that allows water to leak into the center gas lumen | Class II | Terminated | |
| Z-2703-2014 | 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 source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Disposable Patient Circuit that allows water to leak into the center gas lumen | Class II | Terminated | |
| Z-2702-2014 | 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-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Disposable Patient Circuit that allows water to leak into the center gas lumen | Class II | Terminated | |
| Z-2701-2014 | 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 external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Disposable Patient Circuit that allows water to leak into the center gas lumen | Class II | Terminated | |
| Z-2700-2014 | 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 source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Disposable Patient Circuit that allows water to leak into the center gas lumen | Class II | Terminated | |
| Z-2699-2014 | 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 administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Disposable Patient Circuit that allows water to leak into the center gas lumen | Class II | Terminated | |
| Z-0360-06 | Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***. | A medical device firm changed the labeling of its respiratory gas humidifier by revising the protocol for higher level disinfectants to be used by healthcare practitioners. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain