Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012971441

FEI Number

3012971441

Entity Name

Vapotherm Inc.

City/State/Country

Exeter, NH, US

Establishment Address

100 Domain Dr, Exeter, NH 03833, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VAPOTHERM, INC. (Owner Number: 9038880)

Owner / Operator Contact Address

100 Domain Drive, --, Exeter, NH 03833, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ProSoft Nasal Cannula FELIX-1 HVT 2 HVT 2 PF-ADPC-LOW HVT 2 AAA-2 Vapotherm Transfer Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2018-12-11
QAV	High Flow/High Velocity Humidified Oxygen Delivery Device	Anesthesiology	Class 2	868.5454	2019-01-18
CBD	Bottle, Collection, Breathing System (Calibrated)	General Hospital	Class 2	880.6740	2020-08-04
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-11-15
QAV	High Flow/High Velocity Humidified Oxygen Delivery Device	Anesthesiology	Class 2	868.5454	2023-02-21
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-10-27
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2026-04-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-02-21
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2018-12-11

Official Correspondent

Neeraj Pardhy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VAPOTHERM, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023209222	Baja Fur S.A. de C.V.	Tijuana Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

Similar Registrations

Registration Number	Establishment Name	Location
3038913749	INVENTEUR, LLC	Saint Petersburg, FL, US
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
2085602	FISHER & PAYKEL HEALTHCARE, INC.	IRVINE, CA, US
3015084765	GUANG DONG EDA TECHNOLOGY CO., LTD.	Dongguan City Guangdong, CN
3009831876	MASIMO CORPORATION	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012971441. Last updated year: 2026. Please use registration number 3012971441 when referencing this establishment in official correspondence.